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2. Acute kidney injury prediction for non-critical care patients: a retrospective external and internal validation study

Author

Adiyeke, Esra, Ren, Yuanfang, Shickel, Benjamin, Ruppert, Matthew M., Guan, Ziyuan, Kane-Gill, Sandra L., Murugan, Raghavan, Amatullah, Nabihah, Stottlemyer, Britney A., Tran, Tiffany L., Ricketts, Dan, Horvat, Christopher M, Rashidi, Parisa, Bihorac, Azra, and Ozrazgat-Baslanti, Tezcan

Subjects
Computer Science - Machine Learning, Computer Science - Artificial Intelligence
Abstract

Background: Acute kidney injury (AKI), the decline of kidney excretory function, occurs in up to 18% of hospitalized admissions. Progression of AKI may lead to irreversible kidney damage. Methods: This retrospective cohort study includes adult patients admitted to a non-intensive care unit at the University of Pittsburgh Medical Center (UPMC) (n = 46,815) and University of Florida Health (UFH) (n = 127,202). We developed and compared deep learning and conventional machine learning models to predict progression to Stage 2 or higher AKI within the next 48 hours. We trained local models for each site (UFH Model trained on UFH, UPMC Model trained on UPMC) and a separate model with a development cohort of patients from both sites (UFH-UPMC Model). We internally and externally validated the models on each site and performed subgroup analyses across sex and race. Results: Stage 2 or higher AKI occurred in 3% (n=3,257) and 8% (n=2,296) of UFH and UPMC patients, respectively. Area under the receiver operating curve values (AUROC) for the UFH test cohort ranged between 0.77 (UPMC Model) and 0.81 (UFH Model), while AUROC values ranged between 0.79 (UFH Model) and 0.83 (UPMC Model) for the UPMC test cohort. UFH-UPMC Model achieved an AUROC of 0.81 (95% confidence interval [CI] [0.80, 0.83]) for UFH and 0.82 (95% CI [0.81,0.84]) for UPMC test cohorts; an area under the precision recall curve values (AUPRC) of 0.6 (95% CI, [0.05, 0.06]) for UFH and 0.13 (95% CI, [0.11,0.15]) for UPMC test cohorts. Kinetic estimated glomerular filtration rate, nephrotoxic drug burden and blood urea nitrogen remained the top three features with the highest influence across the models and health centers. Conclusion: Locally developed models displayed marginally reduced discrimination when tested on another institution, while the top set of influencing features remained the same across the models and sites.

Published
2024

4. Brief report: incidence and outcomes of pediatric tracheal intubation-associated cardiac arrests in the ICU-RESUS clinical trial

Author

Nishisaki, Akira, Reeder, Ron W., McGovern, Elizabeth Laverriere, Ahmed, Tageldin, Bell, Michael J., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Diddle, Wesley, Federman, Myke, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Maa, Tensing, Manga, Arushi, McQuillen, Patrick, Meert, Kathleen L., Morgan, Ryan W., Mourani, Peter M., Nadkarni, Vinay M., Naim, Maryam Y., Notterman, Daniel, Palmer, Chella A., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., Sutton, Robert M., and Berg, Robert A.

Published
2024
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5. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan

Author

Horvat, Christopher M., Suresh, Srinivasan, James, Nathan, Aneja, Rajesh K., Au, Alicia K., Berry, Scott, Blumer, Arthur, Bricker, Kelly, Clark, Robert S. B., Dolinich, Heidilyn, Hahner, Sheila, Jockel, Christina, Kalivoda, Jordan, Loar, India, Marasco, Denee, Marcinick, Adrienne, Marroquin, Oscar, O’brien, Jonathan, Pelletier, Jonathan, Ramgopal, Sriram, Venkataraman, Shekhar, Angus, Derek C., and Butler, Gabriella

Published
2024
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6. Early bolus epinephrine administration during pediatric cardiopulmonary resuscitation for bradycardia with poor perfusion: an ICU-resuscitation study

Author

O’Halloran, Amanda J., Reeder, Ron W., Berg, Robert A., Ahmed, Tageldin, Bell, Michael J., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Dean, J. Michael, Diddle, J. Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Kienzle, Martha F., Kilbaugh, Todd J., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Meert, Kathleen L., Mourani, Peter M., Nadkarni, Vinay M., Naim, Maryam Y., Notterman, Daniel, Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Tilford, Bradley, Topjian, Alexis A., Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., Sutton, Robert M., and Morgan, Ryan W.

Published
2024
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8. The Temporal Association of the COVID-19 Pandemic and Pediatric Cardiopulmonary Resuscitation Quality and Outcomes.

Author

Morgan, Ryan W, Wolfe, Heather A, Reeder, Ron W, Alvey, Jessica S, Frazier, Aisha H, Friess, Stuart H, Maa, Tensing, McQuillen, Patrick S, Meert, Kathleen L, Nadkarni, Vinay M, Sharron, Matthew P, Siems, Ashley, Yates, Andrew R, Ahmed, Tageldin, Bell, Michael J, Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A, Carpenter, Todd C, Dean, J Michael, Diddle, J Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L, Franzon, Deborah, Hall, Mark, Hehir, David, Horvat, Christopher M, Huard, Leanna L, Manga, Arushi, Mourani, Peter M, Naim, Maryam Y, Notterman, Daniel, Pollack, Murray M, Sapru, Anil, Schneiter, Carleen, Srivastava, Nerraj, Tabbutt, Sarah, Tilford, Bradley, Viteri, Shirley, Wessel, David, Zuppa, Athena F, Berg, Robert A, and Sutton, Robert M

Subjects
Humans, Heart Arrest, Cardiopulmonary Resuscitation, Retrospective Studies, Prospective Studies, Child, Pandemics, COVID-19, Cardiovascular, Clinical Research, Pediatric, Rehabilitation, Good Health and Well Being, cardiac arrest, cardiopulmonary resuscitation, pediatrics, Nursing, Paediatrics and Reproductive Medicine, Pediatrics
Abstract

ObjectivesThe COVID-19 pandemic resulted in adaptations to pediatric resuscitation systems of care. The objective of this study was to determine the temporal association between the pandemic and pediatric in-hospital cardiac arrest (IHCA) process of care metrics, cardiopulmonary resuscitation (cardiopulmonary resuscitation) quality, and patient outcomes.DesignMulticenter retrospective analysis of a dataset comprising observations of IHCA outcomes pre pandemic (March 1, 2019 to February 29, 2020) versus pandemic (March 1, 2020 to February 28, 2021).SettingData source was the ICU-RESUScitation Project ("ICU-RESUS;" NCT028374497), a prospective, multicenter, cluster randomized interventional trial.PatientsChildren (≤ 18 yr) who received cardiopulmonary resuscitation while admitted to the ICU and were enrolled in ICU-RESUS.InterventionsNone.Measurements and main resultsAmong 429 IHCAs meeting inclusion criteria, occurrence during the pandemic period was associated with higher frequency of hypotension as the immediate cause of arrest. Cardiac arrest physiology, cardiopulmonary resuscitation quality metrics, and postarrest physiologic and quality of care metrics were similar between the two periods. Survival with favorable neurologic outcome (Pediatric Cerebral Performance Category score 1-3 or unchanged from baseline) occurred in 102 of 195 subjects (52%) during the pandemic compared with 140 of 234 (60%) pre pandemic ( p = 0.12). Among survivors, occurrence of IHCA during the pandemic period was associated with a greater increase in Functional Status Scale (FSS) (i.e., worsening) from baseline (1 [0-3] vs 0 [0-2]; p = 0.01). After adjustment for confounders, IHCA survival during the pandemic period was associated with a greater increase in FSS from baseline (+1.19 [95% CI, 0.35-2.04] FSS points; p = 0.006) and higher odds of a new FSS-defined morbidity (adjusted odds ratio, 1.88 [95% CI, 1.03-3.46]; p = 0.04).ConclusionsUsing the ICU-RESUS dataset, we found that relative to the year prior, pediatric IHCA during the first year of the COVID-19 pandemic was associated with greater worsening of functional status and higher odds of new functional morbidity among survivors.

Published
2022

10. Identification of post-cardiac arrest blood pressure thresholds associated with outcomes in children: an ICU-Resuscitation study

Author

Gardner, Monique M., Hehir, David A., Reeder, Ron W., Ahmed, Tageldin, Bell, Michael J., Berg, Robert A., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Dean, J. Michael, Diddle, J. Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Harding, Monica L., Horvat, Christopher M., Huard, Leanna L., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Meert, Kathleen L., Morgan, Ryan W., Mourani, Peter M., Nadkarni, Vinay M., Naim, Maryam Y., Notterman, Daniel, Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., Sutton, Robert M., and Topjian, Alexis A.

Published
2023
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13. Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop

Author

Jackson, Shawn S., Lee, Jennifer J., Jackson, William M., Price, Jerri C., Beers, Sue R., Berkenbosch, John W., Biagas, Katherine V., Dworkin, Robert H., Houck, Constance S., Li, Guohua, Smith, Heidi A. B., Ward, Denham S., Zimmerman, Kanecia O., Curley, Martha A. Q., Horvat, Christopher M., Huang, David T., Pinto, Neethi P., Salorio, Cynthia F., Slater, Rebeccah, Slomine, Beth S., West, Leanne L., Wypij, David, Yeates, Keith O., and Sun, Lena S.

Published
2024
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14. Early Cardiac Arrest Hemodynamics, End-Tidal CO2, and Outcome in Pediatric Extracorporeal Cardiopulmonary Resuscitation: Secondary Analysis of the ICU-RESUScitation Project Dataset (2016–2021)*

Author

Yates, Andrew R., Naim, Maryam Y., Reeder, Ron W., Ahmed, Tageldin, Banks, Russell K., Bell, Michael J., Berg, Robert A., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Dean, J. Michael, Diddle, J. Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Morgan, Ryan W., Mourani, Peter M., Nadkarni, Vinay M., Notterman, Daniel, Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yeh, Justin, Zuppa, Athena F., Sutton, Robert M., and Meert, Kathleen L.

Published
2024
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16. Chest compressions for pediatric organized rhythms: A hemodynamic and outcomes analysis

Author

Zinna, Shairbanu S., Morgan, Ryan W., Reeder, Ron W., Ahmed, Tageldin, Bell, Michael J., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Cooper, Kellimarie K., Michael Dean, J., Wesley Diddle, J., Federman, Myke, Fernandez, Richard, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Harding, Monica L., Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Landis, William P., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Meert, Kathleen L., Mourani, Peter M, Nadkarni, Vinay M., Naim, Maryam Y., Notterman, Daniel, Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., Berg, Robert A., and Sutton, Robert M.

Published
2024
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17. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19

Author

Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, Kutcher, Matthew E, Laffan, Michael A, Lamontagne, Francois, and Le Gal, Grégoire

Subjects
Clinical Trials and Supportive Activities, Clinical Research, Comparative Effectiveness Research, Cardiovascular, Good Health and Well Being, Aged, Anticoagulants, COVID-19, Critical Illness, Female, Hemorrhage, Heparin, Hospital Mortality, Humans, Logistic Models, Male, Middle Aged, Odds Ratio, Respiration, Artificial, Thrombosis, Treatment Failure, COVID-19 Drug Treatment, REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

18. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19

Author

Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Krishnan, Vidya

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Hematology, Transplantation, Good Health and Well Being, Adult, Aged, Anticoagulants, COVID-19, Female, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Hospital Mortality, Humans, Male, Middle Aged, Survival Analysis, Thrombosis, COVID-19 Drug Treatment, ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

19. Therapeutic Anticoagulation with Heparin in Critically Ill Patients with Covid-19.

Author

REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Goligher, Ewan C, Bradbury, Charlotte A, McVerry, Bryan J, Lawler, Patrick R, Berger, Jeffrey S, Gong, Michelle N, Carrier, Marc, Reynolds, Harmony R, Kumar, Anand, Turgeon, Alexis F, Kornblith, Lucy Z, Kahn, Susan R, Marshall, John C, Kim, Keri S, Houston, Brett L, Derde, Lennie PG, Cushman, Mary, Tritschler, Tobias, Angus, Derek C, Godoy, Lucas C, McQuilten, Zoe, Kirwan, Bridget-Anne, Farkouh, Michael E, Brooks, Maria M, Lewis, Roger J, Berry, Lindsay R, Lorenzi, Elizabeth, Gordon, Anthony C, Ahuja, Tania, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Contreras, Aira, Costantini, Todd W, de Brouwer, Sophie, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Eng, Heather F, Escobedo, Jorge, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Froess, Joshua D, Fu, Zhuxuan, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, Girard, Timothy D, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Haniffa, Rashan, Hegde, Sheila M, Hendrickson, Carolyn M, Higgins, Alisa M, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Huang, David T, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei, King, Andrew J, Knudson, M Margaret, Kornblith, Aaron E, and Kutcher, Matthew E

Subjects
REMAP-CAP Investigators, ACTIV-4a Investigators, ATTACC Investigators, Humans, Thrombosis, Critical Illness, Hemorrhage, Heparin, Anticoagulants, Treatment Failure, Respiration, Artificial, Hospital Mortality, Logistic Models, Odds Ratio, Aged, Middle Aged, Female, Male, COVID-19, Clinical Research, Cardiovascular, Clinical Trials and Supportive Activities, Comparative Effectiveness Research, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19.MethodsIn an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge.ResultsThe trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio

Published
2021

20. Therapeutic Anticoagulation with Heparin in Noncritically Ill Patients with Covid-19.

Author

ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Lawler, Patrick R, Goligher, Ewan C, Berger, Jeffrey S, Neal, Matthew D, McVerry, Bryan J, Nicolau, Jose C, Gong, Michelle N, Carrier, Marc, Rosenson, Robert S, Reynolds, Harmony R, Turgeon, Alexis F, Escobedo, Jorge, Huang, David T, Bradbury, Charlotte A, Houston, Brett L, Kornblith, Lucy Z, Kumar, Anand, Kahn, Susan R, Cushman, Mary, McQuilten, Zoe, Slutsky, Arthur S, Kim, Keri S, Gordon, Anthony C, Kirwan, Bridget-Anne, Brooks, Maria M, Higgins, Alisa M, Lewis, Roger J, Lorenzi, Elizabeth, Berry, Scott M, Berry, Lindsay R, Aday, Aaron W, Al-Beidh, Farah, Annane, Djillali, Arabi, Yaseen M, Aryal, Diptesh, Baumann Kreuziger, Lisa, Beane, Abi, Bhimani, Zahra, Bihari, Shailesh, Billett, Henny H, Bond, Lindsay, Bonten, Marc, Brunkhorst, Frank, Buxton, Meredith, Buzgau, Adrian, Castellucci, Lana A, Chekuri, Sweta, Chen, Jen-Ting, Cheng, Allen C, Chkhikvadze, Tamta, Coiffard, Benjamin, Costantini, Todd W, de Brouwer, Sophie, Derde, Lennie PG, Detry, Michelle A, Duggal, Abhijit, Džavík, Vladimír, Effron, Mark B, Estcourt, Lise J, Everett, Brendan M, Fergusson, Dean A, Fitzgerald, Mark, Fowler, Robert A, Galanaud, Jean P, Galen, Benjamin T, Gandotra, Sheetal, García-Madrona, Sebastian, Girard, Timothy D, Godoy, Lucas C, Goodman, Andrew L, Goossens, Herman, Green, Cameron, Greenstein, Yonatan Y, Gross, Peter L, Hamburg, Naomi M, Haniffa, Rashan, Hanna, George, Hanna, Nicholas, Hegde, Sheila M, Hendrickson, Carolyn M, Hite, R Duncan, Hindenburg, Alexander A, Hope, Aluko A, Horowitz, James M, Horvat, Christopher M, Hudock, Kristin, Hunt, Beverley J, Husain, Mansoor, Hyzy, Robert C, Iyer, Vivek N, Jacobson, Jeffrey R, Jayakumar, Devachandran, Keller, Norma M, Khan, Akram, Kim, Yuri, Kindzelski, Andrei L, and King, Andrew J

Subjects
ATTACC Investigators, ACTIV-4a Investigators, REMAP-CAP Investigators, Humans, Thrombosis, Hemorrhage, Heparin, Heparin, Low-Molecular-Weight, Anticoagulants, Hospital Mortality, Survival Analysis, Adult, Aged, Middle Aged, Female, Male, COVID-19, Hematology, Clinical Trials and Supportive Activities, Transplantation, Clinical Research, Cardiovascular, General & Internal Medicine, Medical and Health Sciences
Abstract

BackgroundThrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19.MethodsIn this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level.ResultsThe trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis.ConclusionsIn noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).

Published
2021

21. Lopinavir-ritonavir and hydroxychloroquine for critically ill patients with COVID-19: REMAP-CAP randomized controlled trial

Author

Arabi, Yaseen M, Gordon, Anthony C, Derde, Lennie PG, Nichol, Alistair D, Murthy, Srinivas, Beidh, Farah Al, Annane, Djillali, Swaidan, Lolowa Al, Beane, Abi, Beasley, Richard, Berry, Lindsay R, Bhimani, Zahra, Bonten, Marc JM, Bradbury, Charlotte A, Brunkhorst, Frank M, Buxton, Meredith, Buzgau, Adrian, Cheng, Allen, De Jong, Menno, Detry, Michelle A, Duffy, Eamon J, Estcourt, Lise J, Fitzgerald, Mark, Fowler, Rob, Girard, Timothy D, Goligher, Ewan C, Goossens, Herman, Haniffa, Rashan, Higgins, Alisa M, Hills, Thomas E, Horvat, Christopher M, Huang, David T, King, Andrew J, Lamontagne, Francois, Lawler, Patrick R, Lewis, Roger, Linstrum, Kelsey, Litton, Edward, Lorenzi, Elizabeth, Malakouti, Salim, McAuley, Daniel F, McGlothlin, Anna, Mcguinness, Shay, McVerry, Bryan J, Montgomery, Stephanie K, Morpeth, Susan C, Mouncey, Paul R, Orr, Katrina, Parke, Rachael, Parker, Jane C, Patanwala, Asad E, Rowan, Kathryn M, Santos, Marlene S, Saunders, Christina T, Seymour, Christopher W, Shankar-Hari, Manu, Tong, Steven YC, Turgeon, Alexis F, Turner, Anne M, Van de Veerdonk, Frank Leo, Zarychanski, Ryan, Green, Cameron, Berry, Scott, Marshall, John C, McArthur, Colin, Angus, Derek C, and Webb, Steven A

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Comparative Effectiveness Research, Clinical Research, Clinical Trials and Supportive Activities, Good Health and Well Being, Adult, Antiviral Agents, Bayes Theorem, Critical Illness, Drug Combinations, Humans, Hydroxychloroquine, Lopinavir, Ritonavir, SARS-CoV-2, COVID-19 Drug Treatment, Adaptive platform trial, Intensive care, Pneumonia, Pandemic, COVID-19, Lopinavir-ritonavir, REMAP-CAP Investigators, Public Health and Health Services, Emergency & Critical Care Medicine, Clinical sciences
Abstract

PurposeTo study the efficacy of lopinavir-ritonavir and hydroxychloroquine in critically ill patients with coronavirus disease 2019 (COVID-19).MethodsCritically ill adults with COVID-19 were randomized to receive lopinavir-ritonavir, hydroxychloroquine, combination therapy of lopinavir-ritonavir and hydroxychloroquine or no antiviral therapy (control). The primary endpoint was an ordinal scale of organ support-free days. Analyses used a Bayesian cumulative logistic model and expressed treatment effects as an adjusted odds ratio (OR) where an OR > 1 is favorable.ResultsWe randomized 694 patients to receive lopinavir-ritonavir (n = 255), hydroxychloroquine (n = 50), combination therapy (n = 27) or control (n = 362). The median organ support-free days among patients in lopinavir-ritonavir, hydroxychloroquine, and combination therapy groups was 4 (- 1 to 15), 0 (- 1 to 9) and-1 (- 1 to 7), respectively, compared to 6 (- 1 to 16) in the control group with in-hospital mortality of 88/249 (35%), 17/49 (35%), 13/26 (50%), respectively, compared to 106/353 (30%) in the control group. The three interventions decreased organ support-free days compared to control (OR [95% credible interval]: 0.73 [0.55, 0.99], 0.57 [0.35, 0.83] 0.41 [0.24, 0.72]), yielding posterior probabilities that reached the threshold futility (≥ 99.0%), and high probabilities of harm (98.0%, 99.9% and > 99.9%, respectively). The three interventions reduced hospital survival compared with control (OR [95% CrI]: 0.65 [0.45, 0.95], 0.56 [0.30, 0.89], and 0.36 [0.17, 0.73]), yielding high probabilities of harm (98.5% and 99.4% and 99.8%, respectively).ConclusionAmong critically ill patients with COVID-19, lopinavir-ritonavir, hydroxychloroquine, or combination therapy worsened outcomes compared to no antiviral therapy.

Published
2021

22. Associations Between End-Tidal Carbon Dioxide During Pediatric Cardiopulmonary Resuscitation, Cardiopulmonary Resuscitation Quality, and Survival

Author

Morgan, Ryan W., Reeder, Ron W., Bender, Dieter, Cooper, Kellimarie K., Friess, Stuart H., Graham, Kathryn, Meert, Kathleen L., Mourani, Peter M., Murray, Robert, Nadkarni, Vinay M., Nataraj, Chandrasekhar, Palmer, Chella A., Srivastava, Neeraj, Tilford, Bradley, Wolfe, Heather A., Yates, Andrew R., Berg, Robert A., Sutton, Robert M., Ahmed, Tageldin, Bell, Michael J., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carpenter, Todd C., Carcillo, Joseph A., Dean, J. Michael, Diddle, J. Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L, Franzon, Deborah, Frazier, Aisha H., Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Naim, Maryam Y., Notterman, Daniel, Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Tabbutt, Sarah, Viteri, Shirley, Wessel, David, and Zuppa, Athena F.

Published
2024
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23. Survival With Favorable Neurologic Outcome and Quality of Cardiopulmonary Resuscitation Following In-Hospital Cardiac Arrest in Children With Cardiac Disease Compared With Noncardiac Disease*

Author

Federman, Myke, Sutton, Robert M., Reeder, Ron W., Ahmed, Tageldin, Bell, Michael J., Berg, Robert A., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Dean, J. Michael, Diddle, J. Wesley, Fernandez, Richard, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Kirkpatrick, Theresa, Maa, Tensing, Maitoza, Laura A., Manga, Arushi, McQuillen, Patrick S., Meert, Kathleen L., Morgan, Ryan W., Mourani, Peter M., Nadkarni, Vinay M., Notterman, Daniel, Palmer, Chella A., Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., and Naim, Maryam Y.

Published
2024
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25. Outcomes and characteristics of cardiac arrest in children with pulmonary hypertension: A secondary analysis of the ICU-RESUS clinical trial

Author

Morgan, Ryan W, Reeder, Ron W, Ahmed, Tageldin, Bell, Michael J, Berger, John T, Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A, Carpenter, Todd C, Dean, J Michael, Diddle, J Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L, Franzon, Deborah, Frazier, Aisha H, Friess, Stuart H, Graham, Kathryn, Hall, Mark, Hehir, David A, Himebauch, Adam S, Horvat, Christopher M, Huard, Leanna L, Maa, Tensing, Manga, Arushi, McQuillen, Patrick S, Meert, Kathleen L, Mourani, Peter M, Nadkarni, Vinay M, Naim, Maryam Y, Notterman, Daniel, Page, Kent, Pollack, Murray M, Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P, Srivastava, Neeraj, Tabbutt, Sarah, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A, Yates, Andrew R, Zuppa, Athena F, Berg, Robert A, and Sutton, Robert M

Published
2023
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28. Variability in chest compression rate calculations during pediatric cardiopulmonary resuscitation.

Author

Landis, William P, Morgan, Ryan W, Reeder, Ron W, Graham, Kathryn, Siems, Ashley, Diddle, J Wesley, Pollack, Murray M, Maa, Tensing, Fernandez, Richard P, Yates, Andrew R, Tilford, Bradley, Ahmed, Tageldin, Meert, Kathleen L, Schneiter, Carleen, Bishop, Robert, Mourani, Peter M, Naim, Maryam Y, Friess, Stuart, Burns, Candice, Manga, Arushi, Franzon, Deborah, Tabbutt, Sarah, McQuillen, Patrick S, Horvat, Christopher M, Bochkoris, Matthew, Carcillo, Joseph A, Huard, Leanna, Federman, Myke, Sapru, Anil, Viteri, Shirley, Hehir, David A, Notterman, Daniel A, Holubkov, Richard, Dean, J Michael, Nadkarni, Vinay M, Berg, Robert A, Wolfe, Heather A, Sutton, Robert M, and Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) Investigators the National Heart Lung and Blood Institute ICU-RESUScitation Project Investigators

Subjects
Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN) Investigators the National Heart Lung and Blood Institute ICU-RESUScitation Project Investigators, Humans, Heart Arrest, Cardiopulmonary Resuscitation, Pressure, Research Design, Child, American Heart Association, American Heart Association Guideline, Cardiopulmonary resuscitation, Chest compression rate, Cardiovascular, Clinical Sciences, Nursing, Public Health and Health Services, Emergency & Critical Care Medicine
Abstract

AimThe mathematical method used to calculate chest compression (CC) rate during cardiopulmonary resuscitation varies in the literature and across device manufacturers. The objective of this study was to determine the variability in calculated CC rates by applying four published methods to the same dataset.MethodsThis study was a secondary investigation of the first 200 pediatric cardiac arrest events with invasive arterial line waveform data in the ICU-RESUScitation Project (NCT02837497). Instantaneous CC rates were calculated during periods of uninterrupted CCs. The defined minimum interruption length affects rate calculation (e.g., if an interruption is defined as a break in CCs ≥ 2 s, the lowest possible calculated rate is 30 CCs/min). Average rates were calculated by four methods: 1) rate with an interruption defined as ≥ 1 s; 2) interruption ≥ 2 s; 3) interruption ≥ 3 s; 4) method #3 excluding top and bottom quartiles of calculated rates. American Heart Association Guideline-compliant rate was defined as 100-120 CCs/min. A clinically important change was defined as ±5 CCs/min. The percentage of events and epochs (30 s periods) that changed Guideline-compliant status was calculated.ResultsAcross calculation methods, mean CC rates (118.7-119.5/min) were similar. Comparing all methods, 14 events (7%) and 114 epochs (6%) changed Guideline-compliant status.ConclusionUsing four published methods for calculating CC rate, average rates were similar, but 7% of events changed Guideline-compliant status. These data suggest that a uniform calculation method (interruption ≥ 1 s) should be adopted to decrease variability in resuscitation science.

Published
2020

29. Association of CPR simulation program characteristics with simulated and actual performance during paediatric in-hospital cardiac arrest

Author

Cashen, Katherine, Sutton, Robert M., Reeder, Ron W., Ahmed, Tageldin, Bell, Michael J., Berg, Robert A., Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A., Carpenter, Todd C., Wesley Diddle, J., Federman, Myke, Fink, Ericka L., Franzon, Deborah, Frazier, Aisha H., Friess, Stuart H., Graham, Kathryn, Hall, Mark, Hehir, David A., Horvat, Christopher M., Huard, Leanna L., Maa, Tensing, Manga, Arushi, McQuillen, Patrick S., Morgan, Ryan W., Mourani, Peter M., Nadkarni, Vinay M., Naim, Maryam Y., Notterman, Daniel, Palmer, Chella A., Pollack, Murray M., Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P., Srivastava, Neeraj, Viteri, Shirley, Wolfe, Heather A., Yates, Andrew R., Zuppa, Athena F., and Meert, Kathleen L.

Published
2023
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30. Delays to Antibiotics in the Emergency Department and Risk of Mortality in Children With Sepsis

Author

Lane, Roni D., primary, Richardson, Troy, additional, Scott, Halden F., additional, Paul, Raina M., additional, Balamuth, Fran, additional, Eisenberg, Matthew A., additional, Riggs, Ruth, additional, Huskins, W. Charles, additional, Horvat, Christopher M., additional, Keeney, Grant E., additional, Hueschen, Leslie A., additional, Lockwood, Justin M., additional, Gunnala, Vishal, additional, McKee, Bryan P., additional, Patankar, Nikhil, additional, Pinto, Venessa Lynn, additional, Sebring, Amanda M., additional, Sharron, Matthew P., additional, Treseler, Jennifer, additional, Wilkes, Jennifer J., additional, and Workman, Jennifer K., additional

Published
2024
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35. Mortality Risk in Pediatric Sepsis Based on C-reactive Protein and Ferritin Levels

Author

Horvat, Christopher M., Fabio, Anthony, Nagin, Daniel S., Banks, Russell K., Qin, Yidi, Park, Hyun-Jung, Kernan, Kate F., Canna, Scott W., Berg, Robert A., Wessel, David, Pollack, Murray M., Meert, Kathleen, Hall, Mark, Newth, Christopher, Lin, John C., Doctor, Allan, Shanley, Tom, Cornell, Tim, Harrison, Rick E., Zuppa, Athena F., Reeder, Ron W., Sward, Kathy, Holubkov, Richard, Notterman, Daniel A., Dean, J. Michael, and Carcillo, Joseph A.

Published
2022
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36. Definitions of adverse events associated with extracorporeal membrane oxygenation in children: results of an international Delphi process from the ECMO-CENTRAL ARC

Author

Alexander, Peta M A, Di Nardo, Matteo, Combes, Alain, Vogel, Adam M, Antonini, Marta Velia, Barrett, Nicholas, Benedetti, Giulia M, Bettencourt, Amanda, Brodie, Daniel, Gómez-Gutiérrez, René, Gorga, Stephen M, Hodgson, Carol, Kapoor, Poonam Malhotra, Le, Jennifer, MacLaren, Graeme, O’Neil, Erika R, Ostermann, Marlies, Paden, Matthew L, Patel, Neil, Rojas-Peña, Alvaro, Said, Ahmed S, Sperotto, Francesca, Willems, Ariane, Vercaemst, Leen, Yoganathan, Ajit P, Lorts, Angela, del Nido, Pedro J, Barbaro, Ryan P, Abecasis, Francisco, Al Foudri, Huda, Anders, Marc M., Angus, Derek C., Annich, Gail M., Arachchillage, Deepa J., Akcan-Arikan, Ayse, Armstrong, Aimee K., Balcells, Joan, Barrett, Meredith, Bartlett, Robert H., Belda-Hofheinz, Sylvia, Bembea, Melania M., Best, Derek J., Bonadonna, Desiree, Boonstra, Philip S., Brogan, Thomas V, Brown, Katherine L, Butragueño-Laiseca, Laura, Butt, Warwick W., Camporota, Luigi, Cardenas, Barbara, Cascarano, Maria T., Caspi, Joseph, Chen, Eric, Chiletti, Roberto, Colombo, Giovanna G., Conte, Marisa L., Crowe, Liz, Cvetkovic, Mirjana, Dalton, Heidi J., Daverio, Marco, Davidson, Mark G., Davis, Carl, DiGeronimo, Robert J., Egbunine, Ariel, Ellis, W. Cory, Fan, Eddy, Foster, Claire C, Fraser, John F., Friedman, Matthew L., Furlong-Dillard, Jamie, Fynn-Thompson, Francis, Garcia, Alejandro V., Geppert, Jeffery, Gillette, Nicole, Grazioli, Lorenzo, Greene, Christina L, Guerguerian, Anne-Marie, Guilliams, Kristin P., Haji Fortis, Jumana Y., Hao, Jianming, Heinsar, Silver, Hejduk, Mark W., Himebauch, Adam S., Horvat, Christopher M., Hoskote, Aparna, Hou, Xiaotong, Hyslop, Robert W., Ibrahim, Nicole, Ito, Takuya, Karagiannidis, Christian, Karam, Oliver, Kaushik, Shubhi, Kilbaugh, Todd J., Kim-Campbell, Nahmah, Kirsch, Roxanne E, Kormos, Robert L., Kornberger, Angela, Krucoff, Mitchell W., Lakshminrusimha, Satyan, LaRovere, Kerri L, Leger, Pierre-Louis, Levy, Philip T., Lorusso, Roberto, Lyster, Haifa, Malone, Matthew P., McMullan, D. Michael, Mečířová, Soña, Mehran, Roxana, Merz, Scott I., Mochizuki, Shuichi, Moler, Frank W., Molla, Kalkidan, Monagle, Paul, Morgan, Gareth J., Morgan, Catherine, Morice, Marie-Claude, Muszynski, Jennifer A., Najaf, Tasnim A., Nellis, Marianne E., Newburger, Jane W., O'Rourke, P. Pearl, Ostadal, Petr, Ozment, Caroline P., Pagani, Francis D., Peek, Giles J., Polito, Angelo, Priest, John R., Raman, Lakshmi, Rintoul, Natalie E., Roy, Nathalie, Rubin, Juli, Rumford, Martha, Rycus, Peter, Ryerson, Lindsay M., Sakamoto, Wakako, Segura-Matute, Susana, Shekar, Kiran, Spinella, Philip C., Spitzer, Ernest, Starr, Joanne P., Stead, Christine, Steffen, Katherine, Steiner, Marie E., Tan, Lucy, Tasker, Robert C., Taylor, J. Michael, Thiagarajan, Ravi R., Tonna, Joseph E., Ubertini, Gina M., van Leeuwen, Grace, Vang, Eric, Ventetuolo, Corey E., Venugopal, Prem S., Weinberg, Allison, Westrope, Claire, Wu, Changfu, Wylie, Gillian, Zeymer, Uwe, Zivick, Elizabeth E., and Zochios, Vasileios

Abstract

Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC), an international collaborative forum committed to facilitating the creation of stakeholder-driven consensus nomenclature and outcomes for clinical trials of medical devices, supported the ECMO Core Elements Needed for Trials Regulation And quality of Life (ECMO-CENTRAL) ARC. The ECMO-CENTRAL ARC was assembled to develop definitions of paediatric ECMO adverse events for use in clinical trials and regulatory device evaluation. An initial candidate list of ECMO adverse events derived from the mechanical circulatory support ARC was supplemented with a review of ECMO-relevant adverse event definitions collated from literature published between Jan 1, 1988, and Feb 20, 2023. Distinct teams of international topic experts drafted separate adverse event definitions that were harmonised to existing literature when appropriate. Draft definitions were revised for paediatric ECMO relevance with input from patients, families, and an international expert panel of trialists, clinicians, statisticians, biomedical engineers, device developers, and regulatory agencies. ECMO-CENTRAL ARC was revised and disseminated across research societies and professional organisations. Up to three rounds of internet-based anonymous surveys were planned as a modified Delphi process. The expert panel defined 13 adverse event definitions: neurological, bleeding, device malfunction, acute kidney injury, haemolysis, infection, vascular access-associated injury, non-CNS thrombosis, hepatic dysfunction, right heart failure, left ventricular overload, lactic acidaemia, and hypoxaemia. Definitional structure varied. Among 165 expert panel members, 114 were eligible to vote and 111 voted. Consensus was achieved for all proposed definitions. Agreement ranged from 82% to 95%. ECMO-CENTRAL ARC paired rigorous development with methodical stakeholder involvement and dissemination to define paediatric ECMO adverse events. These definitions will facilitate new research and the assimilation of data across clinical trials and ECMO device evaluation in children.

Published
2024
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38. Comparing AVPU and Glasgow Coma Scales Among Children Seen by Emergency Medical Services.

Author

Ramgopal, Sriram, Horvat, Christopher M., Cash, Rebecca E., Pelletier, Jonathan H., Martin-Gill, Christian, and Macy, Michelle L.

Subjects
*CROSS-sectional method, *PAIN measurement, *CONSCIOUSNESS, *RESEARCH funding, *PREDICTION models, *RECEIVER operating characteristic curves, *GLASGOW Coma Scale, *EMERGENCY medicine, *EMERGENCY medical services, *RETROSPECTIVE studies, *DESCRIPTIVE statistics, *SEIZURES (Medicine), *STATISTICS, *AIRWAY (Anatomy), *CARDIAC arrest, *THEORY, *DATA analysis software, *REGRESSION analysis, *CHILDREN
Abstract

OBJECTIVES: Consciousness assessment is an important component in the prehospital care of ill or injured children. Both the Glasgow Coma Scale (GCS) and the Alert, Verbal, Pain, Unresponsive (AVPU) scale are used for this purpose. We sought to identify cut points for the GCS to correspond to the AVPU scale for pediatric emergency medical services (EMS) encounters. METHODS: We conducted a retrospective cross-sectional analysis using the 2019-2022 National EMS Information System data set, including children (<18 years) with a GCS and AVPU score. We evaluated several approaches to develop cut points for the GCS within the AVPU scale and reported measures of performance. RESULTS: Of 6 186 663 pediatric encounters, 4 311 598 with both GCS and AVPU documentation were included (median age was 10 years [interquartile range 3-15]; 50.9% boys). Lower AVPU scores correlated with life-sustaining procedures, including those for airway management, seizure, and cardiac arrest. Optimal GCS cut points obtained via a grid-based search were 14 to 15 for alert, 11 to 13 for verbal, 7 to 10 for pain, and 3 to 6 for unresponsive. Overall accuracy was 0.95, with kappa of 0.61. Intraclass F1 statistics were lower for verbal (0.37) and pain (0.50) categories compared with alert (0.98) and unresponsive (0.78). CONCLUSIONS: We developed a cross-walking between the AVPU and GCS scales. Overall performance was high, though performance within the verbal and pain categories was lower. These findings can be useful to enhance clinician handovers and to aid in the development of EMS-based prediction models. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Early Cardiac Arrest Hemodynamics, End-Tidal Co 2, and Outcome in Pediatric Extracorporeal Cardiopulmonary Resuscitation: Secondary Analysis of the ICU-RESUScitation Project Dataset (2016–2021)*

Author

Yates, Andrew R., primary, Naim, Maryam Y., additional, Reeder, Ron W., additional, Ahmed, Tageldin, additional, Banks, Russell K., additional, Bell, Michael J., additional, Berg, Robert A., additional, Bishop, Robert, additional, Bochkoris, Matthew, additional, Burns, Candice, additional, Carcillo, Joseph A., additional, Carpenter, Todd C., additional, Dean, J. Michael, additional, Diddle, J. Wesley, additional, Federman, Myke, additional, Fernandez, Richard, additional, Fink, Ericka L., additional, Franzon, Deborah, additional, Frazier, Aisha H., additional, Friess, Stuart H., additional, Graham, Kathryn, additional, Hall, Mark, additional, Hehir, David A., additional, Horvat, Christopher M., additional, Huard, Leanna L., additional, Maa, Tensing, additional, Manga, Arushi, additional, McQuillen, Patrick S., additional, Morgan, Ryan W., additional, Mourani, Peter M., additional, Nadkarni, Vinay M., additional, Notterman, Daniel, additional, Pollack, Murray M., additional, Sapru, Anil, additional, Schneiter, Carleen, additional, Sharron, Matthew P., additional, Srivastava, Neeraj, additional, Tilford, Bradley, additional, Viteri, Shirley, additional, Wessel, David, additional, Wolfe, Heather A., additional, Yeh, Justin, additional, Zuppa, Athena F., additional, Sutton, Robert M., additional, and Meert, Kathleen L., additional

Published
2023
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40. Sedation Research in Critically Ill Pediatric Patients: Proposals for Future Study Design From the Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research IV Workshop

Author

Jackson, Shawn S., primary, Lee, Jennifer J., additional, Jackson, William M., additional, Price, Jerri C., additional, Beers, Sue R., additional, Berkenbosch, John W., additional, Biagas, Katherine V., additional, Dworkin, Robert H., additional, Houck, Constance S., additional, Li, Guohua, additional, Smith, Heidi A. B., additional, Ward, Denham S., additional, Zimmerman, Kanecia O., additional, Curley, Martha A. Q., additional, Horvat, Christopher M., additional, Huang, David T., additional, Pinto, Neethi P., additional, Salorio, Cynthia F., additional, Slater, Rebeccah, additional, Slomine, Beth S., additional, West, Leanne L., additional, Wypij, David, additional, Yeates, Keith O., additional, and Sun, Lena S., additional

Published
2023
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46. Establishing outcome‐driven vital signs ranges for children in the prehospital setting.

Author

Ramgopal, Sriram, Horvat, Christopher M., Macy, Michelle L., Cash, Rebecca E., Sepanski, Robert J., and Martin‐Gill, Christian

Subjects
VITAL signs, PULSE oximetry, RESEARCH funding, EVALUATION of medical care, EMERGENCY medicine, EMERGENCY medical services, DESCRIPTIVE statistics, PEDIATRICS, HEART beat, MEDICAL records, ACQUISITION of data, RESPIRATORY measurements, SYSTOLIC blood pressure, CARDIOPULMONARY resuscitation, SENSITIVITY & specificity (Statistics), CHILDREN
Abstract

Background: Vital signs are frequently used in pediatric prehospital assessments and guide protocol utilization. Common pediatric vital sign classification criteria identify >80% of children in the prehospital setting as having abnormal vital signs, though few receive lifesaving interventions (LSIs). We sought to identify data‐driven thresholds for abnormal vital signs by evaluating their association with prehospital LSIs. Methods: We evaluated prehospital care records for children (<18 years) transported to the hospital during 2022 from a large, national repository of emergency medical services (EMS) patient encounters. Predictors of interest were heart rate (HR), respiratory rate (RR), systolic blood pressure (SBP), and pulse oximetry. HR, RR, and SBP were converted to Z‐scores using age‐based distributional models. Our outcome was potential LSIs, defined as performance of selected respiratory procedures, resuscitative interventions, or medication administrations. Using cut point analysis, we identified higher specificity (maximal specificity with a minimum of 25% sensitivity) and higher sensitivity (maximal sensitivity with a minimum of 25% specificity) ranges for each vital sign and evaluated measures of diagnostic accuracy. Results: We included 987,515 children (median age 10 years, IQR 2–15 years). An LSI occurred in 4.3% (2.1% with respiratory procedures, 1.2% with resuscitative interventions, and 2.0% with medication administration). HR, RR, and SBP demonstrated a U‐shaped association with LSIs. Specificities ranged from 84.1% to 93.7% for higher specificity criteria, with RR demonstrating the best performance (sensitivity 84.6%, specificity 27.0%). Sensitivities ranged from 62.3% to 84.4% for higher sensitivity criteria. Conclusions: Cut points for pediatric vital signs were associated with LSIs. Specific age‐adjusted ranges can identify children at higher and lower risk for receipt of LSI. These ranges may be combined with other objective measures to improve the assessment of children in the prehospital setting, assist in optimizing protocol utilization, improve transport decision making, and guide destination selection. [ABSTRACT FROM AUTHOR]

Published
2024
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