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Abstract: Slide Presentations |

PROSPECTIVE DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL ON THE EFFECTS OF LOW-DOSE HYDROCORTISONE INFUSION IN PATIENTS WITH SEVERE SEPSIS FREE TO VIEW

Gianfranco U. Meduri, MD*; Emmel Golden, MD; Reba Umberger, MMSc
Author and Funding Information

University of Tennessee HSC, Memphis, TN


Chest


Chest. 2009;136(4_MeetingAbstracts):45S. doi:10.1378/chest.08-2408
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Abstract

PURPOSE:  Randomized Clinical Trial (RCT) evaluating the effects of low-dose prolonged hydrocortisone infusion on resolution of MODS in severe sepsis.

METHODS:  Patients: severe sepsis < 48h ICU entry - stratified by group (A without shock and MODS < 2; B with shock or MODS > 3). Treatment: Hydrocortisone infusion (10 mg/hr) for 7 days.Primary end point: group A improvement in MODS; group B resolution of shock by day 7.

RESULTS:  Eighty patients: 48 treated vs. 32 placebo (Group A: 17 vs. 13; Group B: 31 vs. 19). Baseline differences (treated vs. control) included (i) higher APACHE III scores (75± 25 vs. 66 ± 11, p = 0.03) and (ii) a trend to higher rates of baseline mechanical ventilation (79% versus 59%, p = 0.06). There was no difference in baseline adrenal insufficiency (35% versus 31%, p = 0.74). Treated group had a significant reduction in median day 7 CRP levels (1.9 (23) versus 13.6 (12), p < 0.0001), duration of mechanical ventilation (5 (5) versus 10 (12), p=0.006), ICU duration (6 (6) versus 12 (18), 0=0.006, and hospital stay (9.5 (8) versus 19 (14), p=0.0005). Despite these highly favorable surrogate endpoints, the ITT analysis demonstrated that treatment with hydrocortisone resulted in worse ICU survival (62.5% versus 81.3%, p=0.07) and hospital survival (52.1% versus 81.3%, p=0.008). In per-protocol analysis, causes of deaths included: 8 progression of shock or MODS, 6 sudden cardiac death (SCD) in patients with ASCVD, and 7 progression of underlying disease.

CONCLUSION:  These findings are limited by a small sample sizes, significant baseline imbalances, unusually excellent outcome in the placebo group, and the significant co-morbidities in the treated group. The potential effect of rebound inflammation in this group of patients was previously reported (Nawab et al. Am J Respir Crit Care Med 2007; 175: A594).

CLINICAL IMPLICATIONS:  In sepsis trials, mortality can be affected by factors not related to the acute infection per se. Mortality outcome trials should incorporate an expanded description of mortality causes.

DISCLOSURE:  Gianfranco Meduri, No Financial Disclosure Information; No Product/Research Disclosure Information

Tuesday, November 3, 2009

2:30 PM - 3:30 PM


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