OBJECTIVES: It is unclear if a low- or high-volume IV fluid resuscitation strategy is better for patients with severe sepsis and septic shock.
DESIGN: Prospective randomized controlled trial.
SETTING: Two adult acute care hospitals within a single academic system.
PATIENTS: Patients with severe sepsis and septic shock admitted from the emergency department to the ICU from November 2016 to February 2018.
INTERVENTIONS: Patients were randomly assigned to a restrictive IV fluid resuscitation strategy (= 60 mL/kg of IV fluid) or usual care for the first 72 hours of care.
MEASUREMENTS AND MAIN RESULTS: We enrolled 109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group. The restrictive group received significantly less resuscitative IV fluid than the usual care group (47.1 vs 61.1 mL/kg; p = 0.01) over 72 hours. By 30 days, there were 12 deaths (21.8%) in the restrictive group and 12 deaths (22.2%) in the usual care group (odds ratio, 1.02; 95% CI, 0.41-2.53). There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events.
CONCLUSIONS: This pilot study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. Although limited by the sample size, we observed no increase in mortality, organ failure, or adverse events. These findings further support that a restrictive IV fluid strategy should be explored in a larger multicenter trial.
Although relevant, this is a pilot study.
I have some doubt about the study results. Since the authors conducted a pilot trial about the restrictive fluid therapy in severe sepsis and septic shock, the amount of resuscitative IV fluid given in either group is 2 to 3 fold less than the amount recommended in the sepsis studies (ProCESS, PromISe or ARISE studies. That is why the authors could not find any differences (both the restrictive group and usual care group patients received less IV fluid).
The treatment of sepsis has evolved greatly in the last 20 years. While early and aggressive resuscitation has been advocated, we are beginning to understand the potential negative consequences of unrestricted IVF. While the small size of this study prevents it from changes practice in isolation, it adds to the growing body of literature suggesting a more restrictive use of IVF (after initial 30mL/kg resuscitation) in sepsis.
This small trial has major shortcomings.
This is a very robust study except for the sample size issue. This study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. However, I was wondering to calculate the outcome results adjusted for the comorbidities, in particular, CHF and CKD.