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1. Platelet Drop and Fibrinolytic Shutdown in Patients With Sepsis.

Author

Semeraro F, Colucci M, Caironi P, Masson S, Ammollo CT, Teli R, Semeraro N, Magnoli M, Salati G, Isetta M, Panigada M, Tonetti T, Tognoni G, Latini R, Pesenti A, and Gattinoni L

Subjects
Aged, Albumins therapeutic use, Biomarkers blood, Female, Fibrinolysis, Humans, Male, Middle Aged, Sepsis complications, Sepsis drug therapy, Sepsis mortality, Survival Analysis, Thrombocytopenia etiology, Platelet Count statistics & numerical data, Sepsis blood
Abstract

Objective: Thrombocytopenia is the most common hemostatic disorder during sepsis and is associated with high mortality. We examined whether fibrinolytic changes precede incident thrombocytopenia and predict outcome in patients with severe sepsis., Design: Nested study from the multicenter, randomized, controlled trial on the efficacy of albumin replacement in severe sepsis or septic shock (the Albumin Italian Outcome Sepsis trial)., Setting: Forty ICUs in Italy., Patients: Three groups of patients were selected: 1) patients with platelet count less than or equal to 50 × 10/L at study entry (n = 85); 2) patients with baseline platelet count greater than or equal to 100 × 10/L who developed thrombocytopenia (≤ 50 × 10/L) within 28 days (n = 100); 3) patients with platelet count always more than or equal to 100 × 10/L (n = 95)., Interventions: Fibrinolytic variables, including fibrinolysis inhibitors and in vivo markers of plasmin generation, were measured on day 1., Measurements and Main Results: Patients with early thrombocytopenia (group 1) and those who developed it later (group 2) had similar illness severity and 90-day mortality, whereas patients without thrombocytopenia (group 3) had milder disease and lower mortality. Fibrinolysis was markedly (and similarly) depressed in groups 1 and 2 as compared with group 3. Major fibrinolytic changes included increased levels of plasminogen activator inhibitor 1 and extensive activation/consumption of thrombin activatable fibrinolysis inhibitor. Most fibrinolytic variables were significantly associated with mortality in univariate models. However, only thrombin activatable fibrinolysis inhibitor level and in vivo markers of fibrinolysis activation, namely plasmin-antiplasmin complex, and D-dimer, were independently associated with mortality after adjustment for Simplified Acute Physiology Score-II score, sex, and platelet count. Furthermore, the coexistence of impaired fibrinolysis and low platelets was associated with an even greater mortality., Conclusions: Impaired fibrinolysis, mainly driven by plasminogen activator inhibitor-1 increase and thrombin activatable fibrinolysis inhibitor activation, is an early manifestation of sepsis and may precede the development of thrombocytopenia. Thrombin activatable fibrinolysis inhibitor level, in particular, proved to be an independent predictor of mortality, which may improve risk stratification of patients with severe sepsis.

Published
2018
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2. Endothelial damage in septic shock patients as evidenced by circulating syndecan-1, sphingosine-1-phosphate and soluble VE-cadherin: a substudy of ALBIOS

Author

Piotti, A., Novelli, D., Meessen, J. M. T. A., Ferlicca, D., Coppolecchia, S., Marino, A., Salati, G., Savioli, M., Grasselli, G., Bellani, G., Pesenti, A., Masson, S., Caironi, P., Gattinoni, L., Gobbi, M., Fracasso, C., Latini, R., Bruzzone, P., Pagan, F., Russo, R., Confalonieri, A., Abbruzzese, C., Vergnano, B., Faenza, S., Siniscalchi, A., Pierucci, E., Noto, A., Pezzi, A., Spanu, P., Parrini, V., Oggioni, R., Pasetti, G. S., Casadio, M. C., Buontempo, R., Carrer, S., Piccoli, F., Rizzi, T., Caricato, A., La Sala, M., Antonaci, A., Fassini, P., Paganini, S., Porta, V., Moise, G., Marell, S., Furia, M., Urbano, M. C., Carobbi, R., Poleni, S., Kandil, H., Ballotta, A., Bettini, F., Sanseverino, M., Gatta, A., Cecchini, F., Guatteri, L., Ciceri, G., Raimondi, F., Colombo, R., Ferraris, S., Borelli, M., Bellato, V., Cancellieri, F., Senni, S., Bertocchi, E., Ferri, P., Moioli, G., Fedele, A., Molin, A., Salsi, P., Brunori, E., Elisei, D., Maggio, G., Nicola, F. G., Cavana, M., Morelli, G., Guarino, A., Isetta, M., Tulli, G., Mangani, V., Rossi, N., Ferrari, M., Bona, F., Vay, M., Bartoli, T., Gallo, M., Vettoretto, K., Morte, M. D., Boselli, E., Puscio, D., Bovo, M., Galzerano, A., Carli, M., Zagara, G., Piotti, A, Novelli, D, Meessen, J, Ferlicca, D, Coppolecchia, S, Marino, A, Salati, G, Savioli, M, Grasselli, G, Bellani, G, Pesenti, A, Masson, S, Caironi, P, Gattinoni, L, Gobbi, M, Fracasso, C, and Latini, R

Subjects
Male, Letter, medicine.medical_treatment, 030204 cardiovascular system & hematology, Critical Care and Intensive Care Medicine, Gastroenterology, 0302 clinical medicine, VE-cadherin, Sphingosine, Septic shock, 80 and over, Medicine, Endothelial dysfunction, Phosphorylation, Aged, 80 and over, lcsh:Medical emergencies. Critical care. Intensive care. First aid, Shock, Biomarker, Glycocalyx, Sphingosine-1-phosphate, Syndecan-1, Aged, Antigens, CD, Biomarkers, Cadherins, Endothelium, Female, Humans, Italy, Lysophospholipids, Middle Aged, Retrospective Studies, Shock, Septic, Extravasation, 3. Good health, CD, Endothelial stem cell, medicine.medical_specialty, Sepsis, 03 medical and health sciences, Internal medicine, Albumins, Settore MED/41 - ANESTESIOLOGIA, Renal replacement therapy, Antigens, business.industry, Septic, Research, Albumin, 030208 emergency & critical care medicine, lcsh:RC86-88.9, medicine.disease, business
Abstract

Background Septic shock is characterized by breakdown of the endothelial glycocalyx and endothelial damage, contributing to fluid extravasation, organ failure and death. Albumin has shown benefit in septic shock patients. Our aims were: (1) to identify the relations between circulating levels of syndecan-1 (SYN-1), sphingosine-1-phosphate (S1P) (endothelial glycocalyx), and VE-cadherin (endothelial cell junctions), severity of the disease, and survival; (2) to evaluate the effects of albumin supplementation on endothelial dysfunction in patients with septic shock. Methods This was a retrospective analysis of a multicenter randomized clinical trial on albumin replacement in severe sepsis or septic shock (the Albumin Italian Outcome Sepsis Trial, ALBIOS). Concentrations of SYN-1, S1P, soluble VE-cadherin and other biomarkers were measured on days 1, 2 and 7 in 375 patients with septic shock surviving up to 7 days after randomization. Results Plasma concentrations of SYN-1 and VE-cadherin rose significantly over 7 days. SYN-1 and VE-cadherin were elevated in patients with organ failure, and S1P levels were lower. SYN-1 and VE-cadherin were independently associated with renal replacement therapy requirement during ICU stay, but only SYN-1 predicted its new occurrence. Both SYN-1 and S1P, but not VE-cadherin, predicted incident coagulation failure. Only SYN-1 independently predicted 90-day mortality. Albumin significantly reduced VE-cadherin, by 9.5% (p = 0.003) at all three time points. Conclusion Circulating components of the endothelial glycocalyx and of the endothelial cell junctions provide insights into severity and progression of septic shock, with special focus on incident coagulation and renal failure. Albumin supplementation lowered circulating VE-cadherin consistently over time. Clinical Trial Registration: ALBIOS ClinicalTrials.gov number NCT00707122.

Published
2021

3. PCSK9 is associated with mortality in patients with septic shock: data from the ALBIOS study

Author

Vecchie, A., Bonaventura, A., Meessen, J., Novelli, D., Minetti, S., Elia, E., Ferrara, D., Ansaldo, A. M., Scaravilli, V., Villa, S., Ferla, L., Caironi, P., Latini, R., Carbone, F., Montecucco, F., Bruzzone, P., Pagan, F., Russo, R., Confalonieri, A., Abbruzzese, C., Vergnano, B., Faenza, S., Siniscalchi, A., Pierucci, E., Noto, A., Pezzi, A., Spanu, P., Parrini, V., Oggioni, R., Pasetti, G. S., Casadio, M. C., Buontempo, R., Carrer, S., Piccoli, F., Rizzi, T., Caricato, A., La Sala, M., Antonaci, A., Fassini, P., Paganini, S., Porta, V., Moise, G., Marell, S., Furia, M., Urbano, M. C., Carobbi, R., Poleni, S., Kandil, H., Ballotta, A., Bettini, F., Sanseverino, M., Gatta, A., Cecchini, F., Guatteri, L., Ciceri, G., Raimondi, F., Colombo, R., Ferraris, S., Borelli, M., Bellato, V., Cancellieri, F., Senni, S., Sacchi, N., Ferri, P., Moioli, G., Fedele, A., Molin, A., Salati, G., Salsi, P., Brunori, E., Elisei, D., Maggio, G., Nicola, F. G., Cavana, M., Morelli, G., Guarino, A., Isetta, M., Tulli, G., Mangani, V., Rossi, N., Ferrari, M., Bona, F., Vay, M., Bartoli, T., Gallo, M., Morte, M. D., Boselli, E., Puscio, D., Galzerano, A., Carli, M., and Zagara, G.

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Inflammation, 030204 cardiovascular system & hematology, Gastroenterology, Sepsis, PCSK9, sepsis, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Settore MED/41 - ANESTESIOLOGIA, Internal Medicine, Medicine, Humans, pentraxin 3, Aged, business.industry, Proportional hazards model, Septic shock, Septic, Mortality rate, mortality, septic shock, Biomarkers, C-Reactive Protein, Female, Italy, Middle Aged, Proprotein Convertase 9, Serum Amyloid P-Component, Shock, Septic, Shock, PTX3, medicine.disease, 030104 developmental biology, Quartile, Biomarker (medicine), medicine.symptom, business
Abstract

Background Pro-protein convertase subtilisin/kexin 9 (PCSK9) is a proenzyme primarily known to regulate low-density lipoprotein receptor re-uptake on hepatocytes. Whether PCSK9 can concurrently trigger inflammation or not remains unclear. Here, we investigated the potential association between circulating levels of PCSK9 and mortality in patients with severe sepsis or septic shock. Methods Plasma PCSK9 levels at days 1, 2 and 7 were measured in 958 patients with severe sepsis or septic shock previously enrolled in the Albumin Italian Outcome Sepsis (ALBIOS) trial. Correlations between levels of PCSK9 and pentraxin 3 (PTX3), a biomarker of disease severity, were evaluated with ranked Spearman's coefficients. Cox proportional hazards models were used to assess the association of PCSK9 levels at day 1 with 28- and 90-day mortality. Results Median plasma PCSK9 levels were 278 [182-452] ng mL-1 on day 1. PCSK9 correlated positively with PTX3 at the three time-points, and patients with septic shock within the first quartile of PCSK9 showed higher levels of PTX3. Similar mortality rates were observed in patients with severe sepsis across PCSK9 quartiles. Patients with septic shock with lower PCSK9 levels on day 1 (within the first quartile) showed the highest 28- and 90-day mortality rate as compared to other quartiles. Conclusion In our sub-analysis of the ALBIOS trial, we found that patients with septic shock presenting with lower plasma PCSK9 levels experienced higher mortality rate. Further studies are warranted to better evaluate the pathophysiological role of PCSK9 in sepsis.

Published
2021

4. Albumin replacement in patients with severe sepsis or septic shock

Author

Gattinoni L, Caironi P, Pesenti A, Fumagalli R, Tognoni G, Romero M, Latini R, Masson S, Vincent JL, Suter PM, Valsecchi MG, Santosuosso A, Cavana M, Ortu A, Gabini R, Perno S, Anelli A, Amoruso R, Ferraris S, Borelli M, Massei R, Riva I, Poli G, Papagni G, Bortone F, Mamprin F, Keim R, Brivio M, Colageo U, Mimii EP, Sangiorgi G, Siniscalchi A, Pierucci E, Giovannitti A, Gentile C, Pascucci F, Antonini B, Zummo U, Valsecchi R, Cerisara M, Trezzi T, Dossena A, Ribola A, Tamayo L, Zoppellari R, Volta CA, Mangani V, Fanfani E, Chelazzi C, Bartoli T, Parrini V, Oggioni R, Fedele A, Molin A, Berri C, Guarino A, Isetta M, Bonfiglio M, Tissino F, Silvestri L, Milanesi M, Sbrana G, Motta E, Iannaco I, Casadio MC, Pasetti GS, Palandini A, Cascione C, Puscio D, Cellai F, Boccalatte D, Silvestri S, Fausto CI, Lupo V, Zompanti V, Iacobone E, Gattari D, Ronzoni G, Beck E, Francesconi S, Colombo R, Raimondi F, Castelli A, De Gasperi A, Radrizzani D, Ferla LE, Giudici R, Bellato V, Bordone G, Gavazzeni V, Lesmo A, Ripamonti D, Vesconi S, Papoff A, Rossi A, Noto A, Pezzi A, Zanforlin G, Kandil H, Ballotta A, Bettini F, Vaghi GM, Rossi S, Pessina C, Casagrande D, Trivellato A, Costagli V, Moise G, Furla M, Marelli S, Caspani L, Panigada M, Bruzzone P, Isgrò S, Abbruzzese C, Tagliabue P, Solca M, Bonazzi M, Cattaneo A, Rossi N, Andreoni P, Pasetto A, Girardis M, Barbieri E, Piazza O, Zagara G, Bono M, Galzerano A, Garzilli T, Dentini N, Bindi M, Biancofiore G, Mercante WP, Disconzi MM, Todesco N, Lunardi S, Sani E, Carli M, Bracciotti G, Gori V, Braccini P, Maggio G, Braschi A, Bottazzi A, Iotti G, Nicora B, Salati G, Salsi P, Antonelli M, Pennisi MA, Bello G, Caccese R, D'Ambrosio M, Rocco M, Sanseverino M, Gatta A, Nastasi M, Corsi A, Facondini F, Franchi F, Mongelli P, Ferrario M, Carulli F, Del Curto S, Schiappacasse G, Dalpiaz C, Armani S, Verderosa I, Marzullo A, Tonetti F, De Piero ME, Livigni S, Fiore G, Cerutti A, Erbetta S, Napolitano R, Pastorelli M, Bona F, Debernardi F, Gallo M, Segala V, Parigi L, Perzolla D, Marson F, Chiarandini P, Cammarano C, Sermann G, De Lucia S, Frigerio A, Distaso F, Franco R, Bossi E, Laudi C, De Nardin M, Violo T, Lazzari F, Vestali A, Della Mora E, Polati E, Martini A, Cristallini S, Totaro C, Milan B, Dan M, Ruberti S, Danzi V., GIARRATANO, Antonino, RAINERI, Santi Maurizio, CORTEGIANI, Andrea, Caironi, P, Tognoni, G, Masson, S, Fumagalli, R, Pesenti, A, Romero, M, Fanizza, C, Caspani, L, Faenza, S, Grasselli, G, Iapichino, G, Antonelli, M, Parrini, V, Fiore, G, Latini, R, Gattinoni, L, Caironi P, Tognoni G, Masson S, Fumagalli R, Pesenti A, Romero M, Fanizza C, Caspani L, Faenza S, Grasselli G, Iapichino G, Antonelli M, Parrini V, Fiore G, Latini R, Gattinoni L, Vincent JL, Suter PM, Valsecchi MG, Santosuosso A, Cavana M, Ortu A, Gabini R, Perno S, Anelli A, Amoruso R, Ferraris S, Borelli M, Massei R, Riva I, Poli G, Papagni G, Bortone F, Mamprin F, Keim R, Brivio M, Colageo U, Mimii EP, Sangiorgi G, Siniscalchi A, Pierucci E, Giovannitti A, Gentile C, Pascucci F, Antonini B, Zummo U, Valsecchi R, Cerisara M, Trezzi T, Dossena A, Ribola A, Tamayo L, Zoppellari R, Volta CA, Mangani V, Fanfani E, Chelazzi C, Bartoli T, Oggioni R, Fedele A, Molin A, Berri C, Guarino A, Isetta M, Bonfiglio M, Tissino F, Silvestri L, Milanesi M, Sbrana G, Motta E, Iannaco I, Casadio MC, Pasetti GS, Palandini A, Cascione C, Puscio D, Cellai F, Boccalatte D, Silvestri S, Fausto CI, Lupo V, Zompanti V, Iacobone E, Gattari D, Ronzoni G, Beck E, Francesconi S, Colombo R, Raimondi F, Castelli A, De Gasperi A, Radrizzani D, Ferla LE, Giudici R, Bellato V, Bordone G, Gavazzeni V, Lesmo A, Ripamonti D, Vesconi S, Papoff A, Rossi A, Noto A, Pezzi A, Zanforlin G, Kandil H, Ballotta A, Bettini F, Vaghi GM, Rossi S, Pessina C, Casagrande D, Trivellato A, Costagli V, Moise G, Furla M, Marelli S, Panigada M, Bruzzone P, Isgrò S, Abbruzzese C, Tagliabue P, Solca M, Bonazzi M, Cattaneo A, Rossi N, Andreoni P, Pasetto A, Girardis M, Barbieri E, Piazza O, Giarratano A, Raineri SM, Cortegiani A, Zagara G, Bono M, Galzerano A, Garzilli T, Dentini N, Bindi M, Biancofiore G, Mercante WP, Disconzi MM, Todesco N, Lunardi S, Sani E, Carli M, Bracciotti G, Gori V, Braccini P, Maggio G, Braschi A, Bottazzi A, Iotti G, Nicora B, Salati G, Salsi P, Pennisi MA, Bello G, Caccese R, D'Ambrosio M, Rocco M, Sanseverino M, Gatta A, Nastasi M, Corsi A, Facondini F, Franchi F, Mongelli P, Ferrario M, Carulli F, Del Curto S, Schiappacasse G, Dalpiaz C, Armani S, Verderosa I, Marzullo A, Tonetti F, De Piero ME, Livigni S, Cerutti A, Erbetta S, Napolitano R, Pastorelli M, Bona F, Debernardi F, Gallo M, Segala V, Parigi L, Perzolla D, Marson F, Chiarandini P, Cammarano C, Sermann G, De Lucia S, Frigerio A, Distaso F, Franco R, Bossi E, Laudi C, De Nardin M, Violo T, Lazzari F, Vestali A, Della Mora E, Polati E, Martini A, Cristallini S, Totaro C, Milan B, Dan M, Ruberti S, and Danzi V

Subjects
Male, medicine.medical_specialty, ALBUMIN, SEPSIS, SEVERE SEPSIS, SEPTIC SHOCK, Sepsi, Serum albumin, Settore MED/41 - Anestesiologia, Aged, Albumins, Female, Humans, Isotonic Solutions, Middle Aged, Rehydration Solutions, Sepsis, Serum Albumin, Shock, Septic, Survival Rate, Treatment Outcome, Intensive care, medicine, albumin replacement, Survival rate, Isotonic Solution, Medicine (all), SEPSIS, biology, business.industry, Septic shock, Rehydration Solution, Septic, Albumin, SEPTIC SHOCK, Organ dysfunction, Shock, General Medicine, medicine.disease, Surgery, Anesthesia, Relative risk, biology.protein, medicine.symptom, business, Human
Abstract

BACKGROUND: Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis, its efficacy has not been fully established. METHODS: In this multicenter, open-label trial, we randomly assigned 1818 patients with severe sepsis, in 100 intensive care units (ICUs), to receive either 20% albumin and crystalloid solution or crystalloid solution alone. In the albumin group, the target serum albumin concentration was 30 g per liter or more until discharge from the ICU or 28 days after randomization. The primary outcome was death from any cause at 28 days. Secondary outcomes were death from any cause at 90 days, the number of patients with organ dysfunction and the degree of dysfunction, and length of stay in the ICU and the hospital. RESULTS: During the first 7 days, patients in the albumin group, as compared with those in the crystalloid group, had a higher mean arterial pressure (P = 0.03) and lower net fluid balance (P

Published
2014

5. Platelet Drop and Fibrinolytic Shutdown in Patients With Sepsis

Author

Antonio Pesenti, Giovanni Salati, Roberto Latini, Fabrizio Semeraro, Luciano Gattinoni, Tommaso Tonetti, Roberto Teli, Gianni Tognoni, Mario Colucci, Mauro Panigada, Michele Isetta, Michela Magnoli, Nicola Semeraro, Concetta T. Ammollo, Serge Masson, Pietro Caironi, Semeraro F., Colucci M., Caironi P., Masson S., Ammollo C.T., Teli R., Semeraro N., Magnoli M., Salati G., Isetta M., Panigada M., Tonetti T., Tognoni G., Latini R., Pesenti A., and Gattinoni L.

Subjects
Male, medicine.medical_specialty, Plasmin, medicine.medical_treatment, 030204 cardiovascular system & hematology, Severe sepsi, Critical Care and Intensive Care Medicine, Gastroenterology, Sepsis, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Albumins, Internal medicine, Septic shock, Fibrinolysis, Humans, Medicine, Fibrinolysi, Platelet, Thrombin activatable fibrinolysis inhibitor, Survival analysis, Aged, Platelet Count, business.industry, 030208 emergency & critical care medicine, Middle Aged, medicine.disease, Survival Analysis, Thrombocytopenia, 3. Good health, chemistry, Plasminogen activator inhibitor-1, Female, business, Plasminogen activator, Biomarkers, medicine.drug
Abstract

Objective Thrombocytopenia is the most common hemostatic disorder during sepsis and is associated with high mortality. We examined whether fibrinolytic changes precede incident thrombocytopenia and predict outcome in patients with severe sepsis. Design Nested study from the multicenter, randomized, controlled trial on the efficacy of albumin replacement in severe sepsis or septic shock (the Albumin Italian Outcome Sepsis trial). Setting Forty ICUs in Italy. Patients Three groups of patients were selected: 1) patients with platelet count less than or equal to 50 × 10/L at study entry (n = 85); 2) patients with baseline platelet count greater than or equal to 100 × 10/L who developed thrombocytopenia (≤ 50 × 10/L) within 28 days (n = 100); 3) patients with platelet count always more than or equal to 100 × 10/L (n = 95). Interventions Fibrinolytic variables, including fibrinolysis inhibitors and in vivo markers of plasmin generation, were measured on day 1. Measurements and main results Patients with early thrombocytopenia (group 1) and those who developed it later (group 2) had similar illness severity and 90-day mortality, whereas patients without thrombocytopenia (group 3) had milder disease and lower mortality. Fibrinolysis was markedly (and similarly) depressed in groups 1 and 2 as compared with group 3. Major fibrinolytic changes included increased levels of plasminogen activator inhibitor 1 and extensive activation/consumption of thrombin activatable fibrinolysis inhibitor. Most fibrinolytic variables were significantly associated with mortality in univariate models. However, only thrombin activatable fibrinolysis inhibitor level and in vivo markers of fibrinolysis activation, namely plasmin-antiplasmin complex, and D-dimer, were independently associated with mortality after adjustment for Simplified Acute Physiology Score-II score, sex, and platelet count. Furthermore, the coexistence of impaired fibrinolysis and low platelets was associated with an even greater mortality. Conclusions Impaired fibrinolysis, mainly driven by plasminogen activator inhibitor-1 increase and thrombin activatable fibrinolysis inhibitor activation, is an early manifestation of sepsis and may precede the development of thrombocytopenia. Thrombin activatable fibrinolysis inhibitor level, in particular, proved to be an independent predictor of mortality, which may improve risk stratification of patients with severe sepsis.

Published
2018

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