Effect of interferon gamma on infection-related death in patients with severe injuries. A randomized, double-blind, placebo-controlled trial. Arch Surg 1994 Oct;129(10):1031-41; discussion 1042
Date
10/01/1994Pubmed ID
7944932DOI
10.1001/archsurg.1994.01420340045008Scopus ID
2-s2.0-0028046930 (requires institutional sign-in at Scopus site) 122 CitationsAbstract
OBJECTIVE: To assess the efficacy of interferon gamma in reducing infection and death in patients sustaining severe injury.
DESIGN: Multicenter, randomized, double-blind, placebo-controlled trial with observation for 60 days and until discharge for patients with major infection on day 60.
SETTING: Nine university-affiliated level 1 trauma centers.
PATIENTS: Four hundred sixteen patients with severe injuries, assessed by Injury Severity Score and degree of contamination.
INTERVENTION: Recombinant human interferon gamma, 100 micrograms, was administered subcutaneously once daily for 21 days (or until patient discharge if prior to 21 days) as an adjunct to standard antibiotic and supportive therapy.
MAIN OUTCOME MEASURES: Incidence of major infection, death related to infection, and death.
RESULTS: Infection rates were similar in both treatment groups; however, patients treated with interferon gamma experienced fewer deaths related to infection (seven [3%] vs 18 [9%]; P = .008) and fewer overall deaths (21 [10%] vs 30 [14%]; P = .17). While 12 early deaths (days 1 through 7) occurred in each treatment group, late death occurred in 18 placebo-treated patients and nine in interferon gamma-treated patients. The results were dominated by findings at one center, which had the highest enrollment and higher infection and death rates. Statistical analysis did not eliminate the possibility of an unidentified imbalance between arms as an explanation for the results.
CONCLUSION: Further evaluation is required to determine the validity of the observed reduction in infection-related deaths in patients treated with interferon gamma.
Author List
Dries DJ, Jurkovich GJ, Maier RV, Clemmer TP, Struve SN, Weigelt JA, Stanford GG, Herr DL, Champion HR, Lewis FRMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Double-Blind Method
Female
Humans
Injury Severity Score
Interferon-gamma
Male
Middle Aged
Recombinant Proteins
Survival Analysis
Treatment Outcome
Wounds and Injuries