International sepsis trial (INTERSEPT): Role and impact of a clinical evaluation committee

Critical Care Medicine

Volumn 24, Issue 9, 1996, Pages 1441-1447

  Sprung, Charles L ^a,e   Finch, Roger G ^b   Thijs, Lambertus G ^c   Glauser, Michel P ^d  

^a HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^b UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^c VU UNIVERSITY AMSTERDAM   (Netherlands)

^d LAUSANNE UNIVERSITY HOSPITAL   (Switzerland)

^e HEBREW UNIVERSITY OF JERUSALEM   (Israel)

Author keywords

antimicrobial therapy; Clinical Evaluation Committee; clinical trials; critical illness; do not resuscitate orders; medical surgical management; pharmacology; sepsis; septic shock; tumor necrosis factor

Indexed keywords

TUMOR NECROSIS FACTOR ANTIBODY;

ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG APPROVAL; DRUG EFFICACY; DRUG RESEARCH; HUMAN; INTERNATIONAL COOPERATION; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PATIENT SELECTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SEPTIC SHOCK; STATISTICAL ANALYSIS;

EID: 0029788247     PISSN: 00903493     EISSN: None     Source Type: Journal    
DOI: 10.1097/00003246-199609000-00003     Document Type: Article

References (16)

1. Bone RC, Fisher CJ, Clemmer TP, et al: A controlled clinical trial of high-dose methylprednisolone in the treatment of severe sepsis and septic shock. N Engl J Med 1987; 317:653-658
2. VA Systemic Sepsis Cooperative Study Group: Effect of high-dose glucocorticoid therapy on mortality in patients with clinical signs of systemic sepsis. N Eng J Med 1987; 317:659-665
3. Ziegler EJ, Fisher CJ, Sprung CL, et al: Treatment of Gram-negative bacteremia and septic shock with HA-1A human monoclonal antibody against endotoxin. N Engl J Med 1991; 324:429-436
4. Greenman RL, Schein RMH, Martin MA, et al: A controlled clinical trial of E5 murine monoclonal antibody to endotoxin in the treatment of Gram-negative sepsis. JAMA 1991; 266:1097-1102
5. McCloskey RV, Straube RC, Sanders C, et al: Treatment of septic shock with human monoclonal antibody HA-1A. A randomized, double-blind, placebo- controlled trial. Ann Intern Med 1994; 121: 1-5
6. Dhainaut JFA, Tenaillon A, Le Tulzo Y, et al: Platelet-activating factor receptor antagonist BN 52021 in the treatment of severe sepsis: A randomized, double-blind, placebo-controlled, multicenter clinical trial. Crit Care Med 1994; 22:1720-1728
7. Fisher CJ, Dhainaut JFA, Opal SM, et al: Recombinant human interleukin 1 receptor antagonist in the treatment of patients with sepsis syndrome. Results from a randomized, double-blind, placebo-controlled trial. JAMA 1994; 271: 1836-1843
8. Abraham E, Wunderink R, Silverman H, et al: Efficacy and safety of monoclonal antibody to human tumor necrosis factor alpha in patients with sepsis syndrome. A randomized, controlled, double-blind, multi-center clinical trial. JAMA 1995; 273:934-941
9. Eidelman LA, Sprung CL: Why have new effective therapies for sepsis not been developed? Crit Care Med 1994; 22:1330-1334
10. Cohen J, Carlet J, for the INTERSEPT Study Group: INTERSEPT: An international, multicenter, placebo-controlled trial of monoclonal antibody to human tumor necrosis factor-α in patients with sepsis. Crit Care Med 1996; 24:1431-1440
11. Hellman S, Hellman DS: Of mice but not men. Problems of the randomized clinical trial. N Engl J Med 1991; 324: 1585-1589
12. Sprung CL: Changing attitudes and practices in foregoing life-sustaining treatments. JAMA 1990; 263:2211-2215
13. Sprung CL, Eidelman LA, Pizov R, et al: The influence of alterations in foregoing life-sustaining treatment practices on a clinical sepsis trial. Submitted for publication or the abstract. Sprung CL, Eidelman LA, Pizov R: Incidence and implications of foregoing life-sustaining therapies in a sepsis trial. Crit Care Med, In Press
14. Warren HS, Danner RL, Munford RS: Anti-endotoxin monoclonal antibodies. N Engl J Med 1992; 326:1153-1157
15. Wenzel RP: Anti-endotoxin monoclonal antibodies - A second look. N Engl J Med 1992; 326:1151-1153
16. Knaus WA, Harrell FE, La Brecque JF, et al: Use of predicted risk of mortality to evaluate the efficacy of anticytokine therapy in sepsis. Crit Care Med 1996; 24:46-56