Although IV fluids are given to improve circulation in patients with septic shock, higher fluid volumes have been associated with harm in several studies. An international randomized clinical trial was conducted to evaluate the effects of restriction of IV fluids on mortality and other outcomes in adult patients with septic shock in the ICU.

The researchers screened patients ages 18 years or older with septic shock in the ICU who had received at least 1 L of IV fluid in the 24 hours before screening. Patients were included in the trial if the onset of shock had been within 12 hours before screening. Patients were randomized to either restrictive IV fluid therapy or standard IV fluid therapy. Death from any cause within 90 days after randomization was the primary outcome.

Information on vital status at 90 days was available for 1,545 of the 1,554 patients: 764 in the restrictive-fluid group and 781 in the standard-fluid group. The median cumulative volume of IV fluids administered in the ICU was 1,798 mL in the restrictive-fluid group and 3,811 mL in the standard fluid group.

At 90 days after randomization, the percentage of patients who had died was similar in the two groups: 42.3% in the restrictive-fluid group and 42.1% in the standard-fluid group. Serious adverse events had occurred in 29.4% and 30.8% of patients, respectively. The number of days alive without life support and days alive out of the hospital were also similar in the two groups.

Regarding limitations of the study, the authors note that patients and personnel were aware of group assignments, data on some important cointerventions and hemodynamic factors weren't collected, and there were some protocol violations.