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7. Metformin treatment in young children with fragile X syndrome

Author

Biag, Hazel Maridith B, Potter, Laura A, Wilkins, Victoria, Afzal, Sumra, Rosvall, Alexis, Salcedo‐Arellano, Maria Jimena, Rajaratnam, Akash, Manzano‐Nunez, Ramiro, Schneider, Andrea, Tassone, Flora, Rivera, Susan M, and Hagerman, Randi J

Subjects
Biological Sciences, Medicinal and Biomolecular Chemistry, Chemical Sciences, Genetics, Intellectual and Developmental Disabilities (IDD), Diabetes, Rare Diseases, Fragile X Syndrome, Basic Behavioral and Social Science, Orphan Drug, Pediatric, Brain Disorders, Behavioral and Social Science, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Metabolic and endocrine, Child, Child, Preschool, Humans, Hypoglycemic Agents, Male, Metformin, Neurodevelopmental Disorders, Prognosis, FMR1, fragile X syndrome, metformin, targeted treatments, translational medicine, Clinical Sciences, Medicinal and biomolecular chemistry
Abstract

BackgroundMetformin is a drug commonly used in individuals with type 2 diabetes, obesity, and impaired glucose tolerance. It has a strong safety profile in both children and adults. Studies utilizing the Drosophila model and knock out mouse model of fragile X syndrome (FXS) have found metformin to rescue memory, social novelty deficits, and neuroanatomical abnormalities. These studies provided preliminary evidence that metformin could be used as a targeted treatment for the cognitive and behavioral problems associated with FXS. Previously, a case series of children and adults with FXS treated with metformin demonstrated improvements in irritability, social responsiveness, language, and hyperactivity.MethodsHere, we present nine children with FXS between 2 and 7 years of age who were treated clinically with metformin and monitored for behavioral and metabolic changes.ResultsParent reports and developmental testing before and after metformin are presented. There were improvements in language development and behavior (such as lethargy and stereotypy) in most of the patients.ConclusionThese results support the need for a controlled trial of metformin in children with FXS under 7 years old whose brains are in a critical developmental window and thus may experience a greater degree of clinical benefit from metformin.

Published
2019

15. Review article: The need for more efficient and patient‐oriented drug development pathways in NASH—setting the scene for platform trials

Author

Di Prospero, Nicholas A., Anstee, Quentin M., Mesenbrinck, Peter, Kjær, Mette S, Rivera-Esteban, Jesús, Sena, Elena, Genesca, Joan, Pericas, Juan M, Manzano-Nunez, Ramiro, Institut Català de la Salut, [Pericàs JM, Rivera-Esteban J, Sena E, Manzano R, Genescà J] Unitat Hepàtica, Servei de Medicina Interna, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Di Prospero NA] Janssen Research and Development, Raritan, New Jersey, USA. [Anstee QM] Liver Unit, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. [Mesenbrinck P] Analytics Department, Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA. [Kjaer MS] Novo Nordisk A/S, Bagsværd, Denmark, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Medicaments - Desenvolupament, enfermedades del sistema digestivo::enfermedades hepáticas::hígado graso::esteatosis hepática no alcohólica [ENFERMEDADES], Esteatosi hepàtica - Tractament, Hepatology, técnicas de investigación::desarrollo de medicamentos [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Gastroenterology, Digestive System Diseases::Liver Diseases::Fatty Liver::Non-alcoholic Fatty Liver Disease [DISEASES], Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Pharmacology (medical), Other subheadings::Other subheadings::/drug therapy [Other subheadings], Investigative Techniques::Drug Development [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT]
Abstract

Drug development; Non-alcoholic steatohepatitis; Study designs Desenvolupament de fàrmacs; Esteatohepatitis no alcohòlica; Dissenys d'estudi Desarrollo de fármacos; Esteatohepatitis no alcohólica; Diseños de estudio Background and Aims Non-alcoholic steatohepatitis (NASH) constitutes a significant unmet medical need with a burgeoning field of clinical research and drug development. Platform trials (PT) might help accelerate drug development while lowering overall costs and creating a more patient-centric environment. This review provides a comprehensive and nuanced assessment of the NASH clinical development landscape. Methods Narrative review and expert opinion with insight gained during the EU Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. Results Although NASH represents an opportunity to use adaptive trial designs, including master protocols for PT, there are barriers that might be encountered owing to distinct and sometimes opposing priorities held by these stakeholders and potential ways to overcome them. The following aspects are critical for the feasibility of a future PT in NASH: readiness of the drug pipeline, mainly from large drug companies, while there is not yet an FDA/EMA-approved treatment; the most suitable design (trial Phase and type of population, e.g., Phase 2b for non-cirrhotic NASH patients); the operational requirements such as the scope of the clinical network, the use of concurrent versus non-concurrent control arms, or the re-allocation of participants upon trial adaptations; the methodological appraisal (i.e. Bayesian vs. frequentist approach); patients' needs and patient-centred outcomes; main regulatory considerations and the funding and sustainability scenarios. Conclusions PT represent a promising avenue in NASH but there are a number of conundrums that need addressing. It is likely that before a global NASH PT becomes a reality, ‘proof-of-platform’ at a smaller scale needs to be provided. JMP reports having received consulting fees from Boehringer-Ingelheim, MSD and Novo Nordisk. He has received speaking fees from Gilead, Intercept, and Novo Nordisk, and travel expenses from Gilead, Rubió, Pfizer, Astellas, MSD, CUBICIN, and Novo Nordisk. He has received educational and research support from Madrigal, Gilead, Pfizer, Astellas, Accelerate, Novartis, Abbvie, ViiV, and MSD. Funds from European Commission/EFPIA IMI2 853966-2, IMI2 777377, H2020 847989, and ISCIII PI19/01898. NAdP works for Janssen. QMA is Coordinator of the EU IMI-2 LITMUS consortium, which is funded by the EU Horizon 2020 programme and EFPIA. This multistakeholder consortium includes industry partners. He reports research Grant Funding: Allergan/Tobira, AstraZeneca, Boehringer-Ingelheim, Glaxo SmithKline, Glympse Bio, Intercept, Novartis Pharma AG, Pfizer Ltd. Consultancy: 89Bio, Abbvie/Allergan, Akero, Altimentiv, Altimmune, AstraZeneca, Axcella, Blade, BMS, BNN Cardio, Boehringer-Ingelheim, Cirius, CymaBay, EcoR1, E3Bio, Eli Lilly & Company Ltd., Galmed, Genentech, Genfit SA, Gilead, Grunthal, HistoIndex, Indalo, Intercept Pharma Europe Ltd., Inventiva, IQVIA, Janssen, Johnson & Johnson, Madrigal, MedImmune, Medpace, Merck, Metacrine, NGMBio, North Sea Therapeutics, Novartis, Novo Nordisk A/S, PathAI, Pfizer Ltd., Poxel, ProSciento, Raptor Pharma, Roche, Servier, Shionogi, Terns, The Medicines Company, Viking Therapeutics. Speaker: Abbott Laboratories, Allergan/Tobira, BMS, Clinical Care Options, Falk, Fishawack, Genfit SA, Gilead, Integritas Communications, Kenes, Medscape. Royalties: Elsevier Ltd. PM works for Novartis. MSK is an employee of and a shareholder in Novo Nordisk A/S. JG has received consulting fees from Boehringer-Ingelheim, speaking fees from Echosens and travel expenses from Gilead and Abbie. Funds from ISCIII PI18/00947 and PI21/00691. JRE has received speaking fees from Gilead. FT lab’ work has been supported by the German Research Foundation (DFG, CRC/TR 362) and research grants from Gilead, Allergan, Bristol-Myers Squibb and Inventiva. VR consults for and Intercept, Novo Nordisk, Galmed, Poxel, NGM, Madrigal, Enyo, Sagimet, 89 Bio, Prosciento, Terns, and Theratechnologies, and received grants from Intercept and Gilead.

Published
2023

18. A meta-analysis of the diagnostic accuracy of chest ultrasound for the diagnosis of occult penetrating cardiac injuries in hemodynamically stable patients with penetrating thoracic trauma

Author

Manzano-Nunez, Ramiro, Gomez, Alexandra, Espitia, David, Sierra-Ruiz, Melibea, Gonzalez, Jessica, Rodriguez-Narvaez, Jose G., Castillo, Andrea C., Gonzalez, Alejandro, Orjuela, Jose, Orozco-Martin, Viviana, Bernal, Felipe, Giron, Felipe, Rios, Angela C., Carranza, Paola, Gonzalez-Hadad, Adolfo, García-Perdomo, Herney A., and García, Alberto F.

Published
2021
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20. Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Cui, Yunfeng, Nascimento, Rafael De Oliveira, De Simone, Belinda, Di Saverio, Salomone, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Published
2020
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23. Could resuscitative endovascular balloon occlusion of the aorta improve survival among severely injured patients with post-intubation hypotension?

Author

Manzano-Nunez, Ramiro, Herrera-Escobar, Juan Pablo, DuBose, Joseph, Hörer, Tal, Galvagno, Samuel, Orlas, Claudia Patricia, Parra, Michael W., Coccolini, Federico, Sartelli, Massimo, Falla-Martinez, Juan Camilo, García, Alberto Federico, Chica, Julian, Naranjo, Maria Paula, Sanchez, Alvaro Ignacio, Salazar, Camilo Jose, Calderón-Tapia, Luis Eduardo, Lopez-Castilla, Valeria, Ferrada, Paula, Moore, Ernest E., and Ordonez, Carlos A.

Published
2018
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28. Additional file 1 of Unlocking the potential of TIPS placement as a bridge to elective and emergency surgery in cirrhotic patients: a meta-analysis and future directions for endovascular resuscitation in acute care surgery

Author

Manzano-Nunez, Ramiro, Jimenez-Masip, Alba, Chica-Yanten, Julian, Ibn-Abdelouahab, Abdelaziz, Sartelli, Massimo, de’Angelis, Nicola, Moore, Ernest E., and García, Alberto F.

Abstract

Additional file 1. Supplementary File.

Published
2023
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31. A meta-analysis of the incidence of complications associated with groin access after the use of resuscitative endovascular balloon occlusion of the aorta in trauma patients

Author

Manzano-Nunez, Ramiro, Orlas, Claudia P., Herrera-Escobar, Juan P., Galvagno, Samuel, DuBose, Joseph, Melendez, Juan J., Serna, Jose J., Salcedo, Alexander, Peña, Camilo A., Angamarca, Edison, Horer, Tal, Salazar, Camilo J., Lopez-Castilla, Valeria, Ruiz-Yucuma, Juan, Rodriguez, Fernando, Parra, Michael W., and Ordoñez, Carlos A.

Published
2018
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38. Additional file 4 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 4:. German translation.

Published
2020
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39. Additional file 8 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 8:. Russian translation.

Published
2020
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40. Additional file 5 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Subjects
Software_GENERAL, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Data_FILES, ComputingMilieux_COMPUTERSANDSOCIETY, GeneralLiterature_MISCELLANEOUS
Abstract

Additional file 5:. Italian translation.

Published
2020
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41. Additional file 2 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Subjects
ComputingMilieux_GENERAL, Data_FILES
Abstract

Additional file 2:. Chinese translation.

Published
2020
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42. Additional file 6 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 6:. Portuguese translation.

Published
2020
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43. Additional file 7 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 7:. Spanish translation

Published
2020
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44. Additional file 9 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 9:. Turkish translation.

Published
2020
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46. Additional file 1 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 1:. Arabic translation.

Published
2020
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47. Additional file 3 of Hey surgeons! It is time to lead and be a champion in preventing and managing surgical infections!

Author

Sartelli, Massimo, Coccolini, Federico, Abu-Zidan, Fikri M., Ansaloni, Luca, Bartoli, Stefano, Biffl, Walter, Borghi, Felice, Chouillard, Elie, Yunfeng Cui, Nascimento, Rafael De Oliveira, Simone, Belinda De, Salomone Di Saverio, Duane, Therese, Eckmann, Christian, Eid, Hani O., Gomes, Carlos Augusto, Gomes, Felipe Couto, Hecker, Andreas, Hecker, Birgit, Isik, Arda, Itani, Kamal M. F., Leppaniemi, Ari, Litvin, Andrey, Luppi, Davide, Maier, Ronald, Manzano-Nunez, Ramiro, Marwah, Sanjay, Mazuski, John, Moore, Ernest, Perrone, Gennaro, Rasa, Kemal, Rubio, Ines, Sawyer, Robert, Labricciosa, Francesco M., and Catena, Fausto

Abstract

Additional file 3:. French translation.

Published
2020
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48. Additional file 1 of Effects of very early start of norepinephrine in patients with septic shock: a propensity score-based analysis

Author

Ospina-Tascón, Gustavo, Hernandez, Glenn, Alvarez, Ingrid, Calderón-Tapia, Luis, Manzano-Nunez, Ramiro, Sánchez-Ortiz, Alvaro, Egardo Quiñones, Ruiz-Yucuma, Juan, Aldana, José, Jean-Louis Teboul, Cavalcanti, Alexandre, Backer, Daniel De, and Bakker, Jan

Abstract

Additional file 1: Figure S1. Selection of patients. Table S1. ESTROBE Statement—Checklist for observational studies. Table S2. General characteristics, hemodynamics, perfusion parameters, fluids, vasopressors and clinical outcomes for the complete (pre-matched) population. Figure S2. Time-course of mean arterial pressures (matched cohort). Figure S3. Net fluid balance from the first resuscitation load up to 24 hours (matched cohort). Figure S4. Time-course of norepinephrine for Very Early- and Delayed-VPs from 2 to 8 hours (matched cohort). Figure S5. Time-course of diastolic shock index (HR:DAP ratio) for Very Early- and Delayed-VPs from start of vasopressors up to 8 hours (matched cohort). Figure S6. Time-course of Pulse Pressure for Very Early- and Delayed-VPs from start of vasopressors up to 8 hours (matched cohort). Figure S7 a. Cox-proportional hazard model for risk of death at day-28 for Very Early- and Delayed-VPs in patients fulfilling the septic shock criteria according to the Sepsis 3.0 definition (matched cohort). Figure S7 b. Cox-proportional hazard model for risk of death at day-28 for Very Early- and Delayed-VPs in patients NO fulfilling the septic shock criteria according to the Sepsis 3.0 definition (sepsis-related acute cardiovascular dysfunction). Table S3. Multivariate Cox regression for 28-day mortality (non-matched population: n=337). Table S4. Multivariate Cox regression for 28-day mortality (propensity-matched population including patients using VPs for < 6H: n=216).

Published
2020
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49. Supplemental Material, Supp1 - Pediatric Palliative Care During End of Life: A Privilege of a Few in a Tertiary Referral Hospital From Colombia

Author

Cuervo-Suarez, Maria Isabel, Claros-Hulbert, Angélica, Manzano-Nunez, Ramiro, Muñoz, Mauricio, and García, Ximena

Subjects
111099 Nursing not elsewhere classified, 111702 Aged Health Care, FOS: Health sciences
Abstract

Supplemental Material, Supp1 for Pediatric Palliative Care During End of Life: A Privilege of a Few in a Tertiary Referral Hospital From Colombia by Maria Isabel Cuervo-Suarez, Angélica Claros-Hulbert, Ramiro Manzano-Nunez, Mauricio Muñoz and Ximena García in American Journal of Hospice and Palliative Medicine®

Published
2020
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50. Outcomes and management approaches of resuscitative endovascular balloon occlusion of the aorta based on the income of countries

Author

Manzano-Nunez, Ramiro, McGreevy, David, Orlas, Claudia P., García, Alberto F., Hörer, Tal M., DuBose, Joseph, Ordoñez, Carlos A., Manzano-Nunez, Ramiro, McGreevy, David, Orlas, Claudia P., García, Alberto F., Hörer, Tal M., DuBose, Joseph, and Ordoñez, Carlos A.

Abstract

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) could provide a survival benefit to severely injured patients as it may improve their initial ability to survive the hemorrhagic shock. Although the evidence supporting the use of REBOA is not conclusive, its use has expanded worldwide. We aim to compare the management approaches and clinical outcomes of trauma patients treated with REBOA according to the countries' income based on the World Bank Country and Lending Groups. METHODS: We used data from the AORTA (USA) and the ABOTrauma (multinational) registries. Patients were stratified into two groups: (1) high-income countries (HICs) and (2) low-to-middle income countries (LMICs). Propensity score matching extracted 1:1 matched pairs of subjects who were from an LMIC or a HIC based on age, gender, the presence of pupillary response on admission, impeding hypotension (SBP ≤ 80), trauma mechanism, ISS, the necessity of CPR on arrival, the location of REBOA insertion (emergency room or operating room) and the amount of PRBCs transfused in the first 24 h. Logistic regression (LR) was used to examine the association of LMICs and mortality. RESULTS: A total of 817 trauma patients from 14 countries were included. Blind percutaneous approach and surgical cutdown were the preferred means of femoral cannulation in HICs and LIMCs, respectively. Patients from LMICs had a significantly higher occurrence of MODS and respiratory failure. LR showed no differences in mortality for LMICs when compared to HICs; neither in the non-matched cohort (OR = 0.63; 95% CI: 0.36‑1.09; p = 0.1) nor in the matched cohort (OR = 1.45; 95% CI: 0.63‑3,33; p = 0.3). CONCLUSION: There is considerable variation in the management practices of REBOA and the outcomes associated with this intervention between HICs and LMICs. Although we found significant differences in multiorgan and respiratory failure rates, there were no differences in the risk-adjusted odds of mortality betwe

Published
2020
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