No difference in outcomes with restrictive versus liberal fluid strategy for sepsis-induced hypotension

Référence

The National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network, Shapiro NI, Douglas IS, et al. Early restrictive or liberal fluid management for sepsis-induced hypotension. N Engl J Med 2023;388(6):499-510.

Sommaire

In this multicenter trial from the United States, investigators randomized adult patients with sepsis-induced hypotension (defined as systolic blood pressure < 100 mmHg after at least 1L and up to 3L of intravenous fluid) to receive either restrictive or liberal fluid resuscitation. Patients with severe volume overload or severe volume depletion from causes other than sepsis were excluded. Patients were enrolled and randomized within 4 hours of meeting the criteria for sepsis-induced hypotension. More than 90% of patients were enrolled from the emergency department. In the restrictive strategy (n = 782), patients received vasopressors as the primary treatment for hypotension, followed by intravenous fluid only for those patients with signs of severe intravascular volume depletion. In the liberal strategy (n = 781), patients received either 1L or 2L intravenous fluid initially followed by fluid boluses, and then vasopressors only as needed. The strategies were maintained for 24 hours. The 2 groups had similar baseline characteristics: average age of 59 years, 47% were women, 70% were white, and a similar percentage of patients had diabetes, heart failure, and end-stage renal disease. Both groups received similar volumes of intravenous fluid (a median of 2L) and had a similar percentage of patients who received vasopressors prior to randomization. The most common type of fluid administered was lactated Ringer's solution. As expected, the restrictive group received an overall lower median volume of fluid than did the liberal group in the 24 hours after randomization (mean difference of -2134 mL; 95% CI -2138 to -1949 mL). Additionally, the restrictive group was more likely than the liberal group to receive vasopressors in the first 24 hours (59% vs 37%). Adherence to the protocol was high — 96% for both groups. For the primary outcome of death before discharge home by day 90, no significant difference was detected between the 2 groups (14.0% in restrictive group vs 14.9% in liberal group). The number of serious adverse events was also similar.