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Randomized Controlled Trial
, 19 (1), 21

Low-dose Hydrocortisone Reduces Norepinephrine Duration in Severe Burn Patients: A Randomized Clinical Trial

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Randomized Controlled Trial

Low-dose Hydrocortisone Reduces Norepinephrine Duration in Severe Burn Patients: A Randomized Clinical Trial

Fabienne Venet et al. Crit Care.

Abstract

Introduction: The aim of this study was to assess the effect of low-dose corticosteroid therapy in reducing shock duration after severe burn.

Methods: A placebo-controlled, double-blind, randomized clinical trial (RCT) was performed on two parallel groups in the burn intensive care unit (ICU). Patients were randomized to receive either low-dose corticosteroid therapy or placebo for seven days. A corticotropin test was performed at the time of randomization, before the administration of the treatment dose. Thirty-two severely burned patients with refractory shock (>0.5 μg/kg/min of norepinephrine) were prospectively included in the study.

Results: We included 12 patients in the hydrocortisone-treated group and 15 patients in the placebo group in the final analysis. Among these patients, 21 were nonresponders to the corticotropin test. Median norepinephrine treatment duration (primary objective) was significantly lower in the corticosteroid-treated versus the placebo group (57 hours versus 120 hours, P = 0.035). The number of patients without norepinephrine 72 hours after inclusion was significantly lower in the treated group (P = 0.003, log-rank test analysis). The total quantities of norepinephrine administered to patients were lower in the hydrocortisone-treated versus the placebo group (1,205 μg/kg (1,079 to 2,167) versus 1,971 μg/kg (1,535 to 3,893), P = 0.067). There was no difference in terms of ICU or hospital length of stay, sepsis incidence, cicatrization or mortality.

Conclusions: In this placebo-controlled, randomized, double-blind clinical trial, we show for the first time that the administration of low-dose hydrocortisone in burn patients with severe shock reduces vasopressor administration.

Trial registration: Clinicaltrial.gov NCT00149123 . Registered 6 September 2005.

Figures

Figure 1
Figure 1
Study flow chart. Thirty-two patients were initially randomized in this clinical trial evaluating the effect of low-dose hydrocortisone on shock duration after severe burn injury. Inclusion and exclusion criteria are presented in the figure. At inclusion a corticotropin test was performed in every patient to identify those presenting with relative adrenal insufficiency (RAI). The follow-up duration was nine days. After this follow-up, 12 low-dose hydrocortisone-treated patients and 15 patients treated with placebo were finally included in the statistical analysis.
Figure 2
Figure 2
Individual longitudinal follow-up plots of vasopressor therapy. Vasopressor therapy duration is presented in this figure for the analyzed patients (n = 27). The dashed lines correspond to norepinephrine treatment duration for patients with placebo and the solid lines correspond to norepinephrine treatment duration for patients with corticosteroids. Medians of norepinephrine duration are reported (57 hours in the hydrocortisone-treated group versus 120 hours in the placebo-treated group).
Figure 3
Figure 3
Norepinephrine duration for patients treated with low-dose hydrocortisone and placebo. Thirty-two severely burned patients were initially randomized in this clinical trial evaluating the effect of low-dose hydrocortisone on shock duration after burn. Twelve low-dose hydrocortisone-treated patients (corticosteroids, grey boxes) and 15 patients treated with placebo (placebo, open boxes) were finally included in the statistical analysis. Box plots and individual values of norepinephrine duration (in hours) in low-dose hydrocortisone and placebo-treated groups are presented. Differences between groups were evaluated by using the Mann-Whitney test.
Figure 4
Figure 4
Number of patients without norepinephrine at nine time points during the follow-up. Thirty-two severely burned patients were initially randomized in this clinical trial evaluating the effect of low-dose hydrocortisone on shock duration after burn. Twelve low-dose hydrocortisone-treated patients and 15 patients treated with placebo were finally included in the statistical analysis. The numbers of patients without norepinephrine at nine time points after protocol inclusion are shown. The solid black line corresponds to patients treated with low-dose hydrocortisone. The dashed grey line corresponds to patients treated with placebo. Low-dose hydrocortisone or placebo treatments and follow-up durations are shown. Seventy-two hours after inclusion, the difference of weaned patients between the two groups was evaluated with a Fisher’s exact test.

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