Influence of alterations in foregoing life-sustaining treatment practices on a clinical sepsis trial. The HA-1A Sepsis Study Group.
| Autor: | Sprung CL; Department of Anesthesiology and Critical Care Medicine, Hadassah Hebrew University Medical Center, Hebrew University of Jerusalem, Israel., Eidelman LA, Pizov R, Fisher CJ Jr, Ziegler EJ, Sadoff JC, Straube RC, McCloskey RV |
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| Jazyk: | angličtina |
| Zdroj: | Critical care medicine [Crit Care Med] 1997 Mar; Vol. 25 (3), pp. 383-7. |
| DOI: | 10.1097/00003246-199703000-00002 |
| Abstrakt: | Objectives: To evaluate the timing of foregoing life-sustaining treatments in patients enrolled in a sepsis trial and to determine their influence on patient outcome and trial results. Design: Subset of patients in a prospective, randomized, double-blind, placebo-controlled study. Setting: Twenty-three academic medical centers. Patients: Enrolled patients who had life-sustaining therapies withheld or withdrawn. Measurements and Main Results: The number of patients, types of disorders and interventions, reasons, and timing of withholding and withdrawing life-sustaining treatments and their effect on mortality and trial results were assessed. Foregoing of life-sustaining therapies took place in 117 (22%) of 543 patients and occurred within 72 hrs of study drug administration in 38 (32%) patients. Withholding treatment (60%) was more common than withdrawing treatment (40%), but withdrawing treatment was more frequent (51%) than withholding treatment (20%) in the first 72 hrs of the trial (p < .01). Sixty-one (52%) patients had severe underlying disorders with a poor prognosis. The hospital mortality rate was 94% (of the 117 patients). The mean time (SEM) from withholding or withdrawing of treatment until death was 2.83 +/- 0.57 and 0.32 +/- 0.13 days, respectively (p < .001). Patients who had therapies foregone in the first 24, 48, and 72 hrs after receiving the study drug had higher mortality rates in the first 72 hrs (p < .01). Conclusions: A substantial number of patients enrolled in a sepsis trial had severe underlying diseases and had foregoing of therapies early in the course of the trial, which led to a higher early mortality rate. Enrollment of patients in clinical trials with severe underlying disorders with a high likelihood of having therapies foregone may bias the potential for showing the efficacy of new therapeutic modalities. |
| Databáze: | MEDLINE |
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