Protocolised early de-resuscitation in septic shock (REDUCE): protocol for a randomised controlled multicentre...

Area of Science:

• Critical Care Medicine
• Nephrology
• Intensive Care

Background:

• Fluid overload is a significant contributor to mortality in septic shock patients.
• Current strategies for fluid overload management include fluid restriction or active fluid removal, though evidence for the latter is limited.
• Early intervention may mitigate the adverse effects of fluid overload in septic shock.

Purpose of the Study:

• To evaluate the efficacy and feasibility of an early de-resuscitation protocol in patients with septic shock.
• To assess the proportion of patients achieving a negative cumulative fluid balance by day 3 of intensive care unit (ICU) stay.
• To explore secondary outcomes including fluid balances, incidence of fluid overload, and safety parameters.

Main Methods:

• Patients admitted to the ICU with septic shock will be screened and randomized (1:1) to either the intervention or standard care group.
• The intervention group will follow the REDUCE protocol, involving restricted resuscitation fluids and active de-resuscitation after lactate peak and stabilization.
• Outcomes will be assessed using logistic regression, adjusting for trial site and chronic renal failure.

Main Results:

• Primary outcome: Proportion of patients with negative cumulative fluid balance at day 3 post-ICU admission.
• Secondary outcomes: Cumulative fluid balances during ICU stay, frequency of fluid overload, feasibility, safety, and patient-centered outcomes.
• The REDUCE trial (NCT04931485) aims to provide robust data on early de-resuscitation strategies.

Conclusions:

• The study will provide crucial evidence on the effectiveness of early de-resuscitation in managing fluid overload in septic shock.
• Findings will inform clinical practice regarding fluid management strategies in critically ill patients.
• Results will be disseminated through peer-reviewed publications regardless of outcome.