June 17, 2022
Restriction of Intravenous Fluid in ICU Patients with Septic Shock.
What was the research question?
Does the use of restrictive fluid strategy reduce 90-day mortality in patients with septic shock compared to standard fluid strategy?
How did they do it?
An international, randomized trial at 31 centers in Denmark, Norway, Sweden, Switzerland, Italy, the Czech Republic, the United Kingdom, and Belgium.
1554 patients with septic shock who received at least 1 liter of intravenous fluid within 12 hours of sepsis onset were randomized to receive restricted intravenous fluid (770 patients) or standard intravenous fluid therapy (784 patients).
In the restrictive fluid strategy, patients were allowed to get fluid for evidence of hypoperfusion, fluid loses, dehydration, or for daily intake of at least 1 liter. In the standard group, patients were given fluid as per the surviving sepsis campaign, for fluid loses, dehydration, or for maintenance based on a local protocol.
The primary outcome was 90-day mortality of any caused since randomization.
What did they find?
Median fluid was significantly lower in the restrictive group compared to the standard (1798 vs. 3811 ml).
90-day mortality was not significantly in the restrictive group compared to the standard group (42.3% vs. 42.1%, adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], −4.7 to 4.9; P=0.96).
Serious adverse events in the ICU were not significantly different in the restrictive group compared to the standard (29.4% vs. 30.8%, adjusted absolute difference, −1.7 percentage points; 99% CI, −7.7 to 4.3).
At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.
Are there any limitations?
Patients received some fluid before enrollment.
Some protocol violations occurred.
The assumed difference of 7% in the 90-day mortality may have been large to detect statistical difference.
What does it mean?
Restrictive fluid strategy did not reduce 90-day mortality in patients with septic shock compared to standard fluid strategy.
Continue to use standard fluid strategy as per 2016 surviving sepsis campaign waiting modification of guidelines.