No change in mortality with restricted intravenous fluid therapy in patients with septic shock

Reference

Meyhoff TS, Hjortrup PB, Wetterslev J, et al, for the CLASSIC Trial Group. Restriction of intravenous fluid in ICU patients with septic shock. N Engl J Med 2022;386(26):2459-2470.

Synopsis

In this multisite European study, investigators randomized adult patients admitted to the intensive care unit (ICU) with septic shock to receive restricted intravenous fluid therapy (n = 764) or standard fluid therapy (n = 781). Septic shock was defined as having a lactate level of 2 mmol per liter or higher, requiring ongoing infusions of vasopressors or inotropic agents, and receiving at least 1 liter of fluid prior to screening for trial enrollment. In the restrictive group, patients only received additional intravenous fluid if there was evidence of severe hypoperfusion, to replete documented fluid losses, and to correct dehydration or maintain daily 1 liter fluid intake if the enteral route was contraindicated. In the standard group, there was no upper limit to the amount of intravenous fluid that patients could receive. Patients received their assigned therapy until discharge from the ICU up to a maximum of 90 days. The 2 groups were similar at baseline. The mean volume of intravenous fluid administered at 90 days was 3414 mL in the restrictive group and 5275 mL in the standard group. No significant difference was detected in the primary outcome of all-cause mortality at 90 days (42.3% in restrictive group vs 42.1% in standard group). Additionally, the 2 groups were similar in the number of serious adverse events, the number of days alive without life support, and the number of days alive and out of the hospital at 90 days.