Restrictive fluid strategy does not reduce risk for sepsis-induced hypotension
Among patients with sepsis-induced hypotension, a restrictive fluid strategy was not associated with mortality risk before discharge home by day 90 compared with a liberal fluid strategy, researchers reported.
“Although the administration of large volumes of fluid (a liberal fluid strategy) is a common practice during the initial resuscitative phase of septic shock management, this practice is based on low-quality evidence,” Nathan I. Shapiro, MD, professor of emergency medicine at Beth Israel Deaconess Medical Center and Harvard Medical School, and colleagues wrote in The New England Journal of Medicine. “Arguments based on physiological factors and observational data provide a strong rationale for an alternative approach that uses lower volumes of fluid and earlier initiation of vasopressor agents (a restrictive fluid strategy); this approach is of growing interest.”
Data were derived from National Heart, Lung, and Blood Institute Prevention and Early Treatment of Acute Lung Injury Clinical Trials Network. N Engl J Med. 2023;doi:10.1056/NEJMoa2212663.
For the CLOVERS study, Shapiro and colleagues analyzed data from 1,563 patients from 60 U.S. centers. Researchers randomly assigned patients to a restrictive fluid strategy that prioritized vasopressors and lower IV fluid volumes (n = 782) or a liberal fluid strategy that prioritized higher volumes of IV fluids before vasopressor use (n = 781), both for 24 hours. Randomization occurred within 4 hours after a patient met the criteria for sepsis-induced hypotension refractory to initial treatment with 1 L to 3 L of IV fluid. The primary outcome was all-cause mortality before discharge home by day 90.
Resuscitation therapies administered during the 24-hour protocol period differed between the two groups; less IV fluid was administered in the restrictive fluid group vs. the liberal fluid group (difference of medians, –2,134 mL; 95% CI, –2,318 to –1,949), whereas the restrictive fluid group had earlier, more prevalent and longer duration of vasopressor use.
Death from any cause before discharge home by day 90 occurred in 14% of patients in the restrictive fluid group and 14.9% in the liberal fluid group, for an estimated difference of –0.9 percentage points (95% CI, –4.4 to 2.6; P = .61). Serious adverse events did not differ between the two groups.
“Despite separation between the two groups with respect to the volume of intravenous fluid administered and the use of vasopressors, we detected no significant difference in mortality before discharge home by day 90 (the primary outcome),” the researchers wrote.
The researchers noted that CLOVERS used common clinical characteristics and routine assessments to trigger protocol-directed actions for vasopressor and fluid administration, adding it is possible that one fluid strategy may emerge as more beneficial among specific patient subgroups defined according to clinical or biologic measurements.
“Future initiatives may assess for these types of subgroups and differential treatment effects,” the researchers wrote.
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