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17/04/2012

HEA pas bon en cas de sepsis sévère: Si l'on en croit le "6S trial"

6S Trial.jpg


Le choc hémorragique n'est pas le choc septique, mais on peut s'interroger


Background

Hydroxyethyl starch (HES) is widely used for fluid resuscitation in intensive care  units (ICUs), but its safety and efficacy have not been established in patients with  severe sepsis.

Methods

In this multicenter, parallel-group, blinded trial, we randomly assigned patients with severe sepsis to fluid resuscitation in the ICU with either 6% HES 130/0.42  (Tetraspan) or Ringer’s acetate at a dose of up to 33 ml per kilogram of ideal body  weight per day. The primary outcome measure was either death or end-stage kidney  failure (dependence on dialysis) at 90 days after randomization.

Results

Of the 804 patients who underwent randomization, 798 were included in the modified intention-to-treat population. The two intervention groups had similar baseline  characteristics. At 90 days after randomization, 201 of 398 patients (51%) assigned  to HES 130/0.42 had died, as compared with 172 of 400 patients (43%) assigned to  Ringer’s acetate (relative risk, 1.17; 95% confidence interval [CI], 1.01 to 1.36;  P=0.03); 1 patient in each group had end-stage kidney failure. In the 90-day period,  87 patients (22%) assigned to HES 130/0.42 were treated with renal-replacement therapy versus 65 patients (16%) assigned to Ringer’s acetate (relative risk, 1.35; 95%  CI, 1.01 to 1.80; P=0.04), and 38 patients (10%) and 25 patients (6%), respectively,  had severe bleeding (relative risk, 1.52; 95% CI, 0.94 to 2.48; P=0.09). The results  were supported by multivariate analyses, with adjustment for known risk factors for  death or acute kidney injury at baseline.

Conclusions

Patients with severe sepsis assigned to fluid resuscitation with HES 130/0.42 had an  increased risk of death at day 90 and were more likely to require renal-replacement therapy, as compared with those receiving Ringer’s acetate.

(Funded by the Danish  Research Council and others; 6S ClinicalTrials.gov number, NCT00962156.)

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