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Titolo:
Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study
Autore:
Reinhart, K; Menges, T; Gardlund, B; Zwaveling, JH; Smithes, M; Vincent, JL; Tellado, JM; Salgado-Remigio, A; Zimlichman, R; Withington, S; Tschaikowsky, K; Brase, R; Damas, P; Kupper, H; Kempeni, J; Eiselstein, J; Kaul, M;
Indirizzi:
Univ Jena, Dept Anesthesia & Operat Intens Care, D-6900 Jena, Germany UnivJena Jena Germany D-6900 & Operat Intens Care, D-6900 Jena, Germany Knoll AG, Dept Res & Dev, D-6700 Ludwigshafen, Germany Knoll AG Ludwigshafen Germany D-6700 & Dev, D-6700 Ludwigshafen, Germany CHU Liege, Intens Care Unit, Liege, Belgium CHU Liege Liege BelgiumCHU Liege, Intens Care Unit, Liege, Belgium Hosp Links der Weser, Dept Anesthesia, Bremen, Germany Hosp Links der Weser Bremen Germany r, Dept Anesthesia, Bremen, Germany Univ Erlangen Nurnberg, Inst Anesthesia, Erlangen, Germany Univ Erlangen Nurnberg Erlangen Germany t Anesthesia, Erlangen, Germany Royal London Hosp, Dept Anesthet, London E1 1BB, England Royal London Hosp London England E1 1BB Anesthet, London E1 1BB, England Wolfson Hosp, Dept Intens Med, Holon, Israel Wolfson Hosp Holon IsraelWolfson Hosp, Dept Intens Med, Holon, Israel Hosp Gen Valle Hebron, Dept Internal Med, Barcelona, Spain Hosp Gen Valle Hebron Barcelona Spain pt Internal Med, Barcelona, Spain Hosp Gen Gregorio Maranon, Dept Gen Surg, Madrid, Spain Hosp Gen Gregorio Maranon Madrid Spain on, Dept Gen Surg, Madrid, Spain Erasme Univ Hosp, Dept Intens Care, B-1070 Brussels, Belgium Erasme Univ Hosp Brussels Belgium B-1070 Care, B-1070 Brussels, Belgium Univ Wales Hosp, Intens Therapy Unit, Cardiff CF4 4XW, S Glam, Wales Univ Wales Hosp Cardiff S Glam Wales CF4 4XW rdiff CF4 4XW, S Glam, Wales Acad Ziekenhuis, Dept Surg, Groningen, Netherlands Acad Ziekenhuis Groningen Netherlands Dept Surg, Groningen, Netherlands Karolinska Hosp, Infect Dis Sect, S-10401 Stockholm, Sweden Karolinska Hosp Stockholm Sweden S-10401 Sect, S-10401 Stockholm, Sweden Univ Giessen, Dept Anesthesia & Intens Care, Giessen, Germany Univ Giessen Giessen Germany Anesthesia & Intens Care, Giessen, Germany
Titolo Testata:
CRITICAL CARE MEDICINE
fascicolo: 4, volume: 29, anno: 2001,
pagine: 765 - 769
SICI:
0090-3493(200104)29:4<765:RPTOTA>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
SEPTIC SHOCK; MONOCLONAL-ANTIBODY; FACTOR-ALPHA; INTERLEUKIN-6 IL-6; FUSION PROTEIN; DOUBLE-BLIND; MULTICENTER; CYTOKINE; EFFICACY; SAFETY;
Keywords:
sepsis; interleukin-6; tumor necrosis factor; monoclonal antibody; cytokines; infection; critical illness; clinical trial; septic shock;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Citazioni:
23
Recensione:
Indirizzi per estratti:
Indirizzo: Reinhart, K Univ Jena, Dept Anesthesia & Operat Intens Care, D-6900 Jena, Germany Univ Jena Jena Germany D-6900 ens Care, D-6900 Jena, Germany
Citazione:
K. Reinhart et al., "Randomized, placebo-controlled trial of the anti-tumor necrosis factor antibody fragment afelimomab in hyperinflammatory response during severe sepsis: The RAMSES Study", CRIT CARE M, 29(4), 2001, pp. 765-769

Abstract

Objective: This study investigated whether treatment with the anti-tumor necrosis factor-or monoclonal antibody afelimomab would improve survival in septic patients with serum interleukin (IL)-6 concentrations of >1000 pg/ml,Design: Multicenter, double-blind, randomized, placebo-controlled study. Setting: Eighty-four intensive care units in academic medical centers in Europe and Israel. Patients: A total of 944 septic patients were screened and stratified by the results of a rapid qualitative immunostrip test for serum IL-6 concentrations. Patients with a positive test kit result indicating IL-6 concentrations of>1000 pg/mL were randomized to receive either afelimomab (n = 224) or placebo (n = 222), Patients with a negative IL-6 test (n = 498) were not randomized and were followed up for 28 days. Interventions: Treatment consisted of 15-min infusions of 1 mg/kg afelimomab or matching placebo every 8 hrs for 3 days. Standard surgical and intensive care therapy was otherwise delivered. Measurements and Main Results:The study was terminated prematurely after an interim analysis estimated that the primary efficacy end points would notbe met. The 28-day mortality rate in the nonrandomized patients (39.6%, 197 of 498) was significantly lower (p < .001) than that found in the randomized patients (55.8%, 249 of 446). The mortality rates in the IL-6 test kit positive patients randomized to afelimomab and placebo were similar, 54.0% (121 of 224) vs, 57.7% (128 of 222), respectively. Treatment with afelimomab was not associated with any particular adverse events. Conclusions: The IL-6 immunostrip test identified two distinct sepsis populations with significantly different mortality rates. A small (3.7%) absolute reduction in mortality rate was found in the afelimomab-treated patients. The treatment difference did not reach statistical significance.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 09/07/20 alle ore 23:32:15