Restrictive fluid management and early fluid de-escalation versus usual care in critically ill patients: A feasibility trial protocol for the REDUCE randomized clinical trial

Abstract

Background: Fluid therapy is an essential therapeutic intervention for critically ill patients. Both fluid overload and hypovolemia are associated with poor outcomes. However, the fluid strategy in intensive care units is still controversial, and there is no consensus on using the fluid strategy in patients with circulatory shock. Objectives: To compare the efficacy of protocol-based fluid-restrictive management versus standard care in critically ill patients with circulatory shock. Methods: This is a single-center, feasibility-based, randomized, controlled trial in critically ill patients with circulatory shock receiving either fluid resuscitation or vasopressors in two medical ICUs at Siriraj Hospital. Eligible patients will be randomly allocated in a 1:1 ratio and placed in the restrictive fluid strategy (intervention) group or standard care (control) group. The primary outcome is accumulative fluid balance 72 hours after enrollment. Conclusions: This study will evaluate the efficacy and safety of a protocol-based fluid restrictive strategy in critically ill patients who have circulatory shock and are receiving fluid resuscitation or vasopressors.