NCT04931485

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

Protocolised Early De-Resuscitation in Septic Shock (REDUCE) - a Randomised Controlled Multi-centre Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Recent studies have questioned the safety of current fluid resuscitation strategies in patients with septic shock as prospective and observational data suggesting that the resulting fluid overload is associated with mortality. Two strategies have evolved to prevent or minimize fluid overload: restrictive fluid administration or active removal of accumulated fluid. While several small trials show benefits with a restrictive fluid administration regimen, active protocolized de-resuscitation was scarcely evaluated. The combination of both strategies yet warrants systematic evaluation. Aim: This study aims to assess the efficacy and feasibility of an early active de-resuscitation protocol in patients with septic shock. We hypothesize that the application of a structured early de-resuscitation protocol versus standard of care will lead to less fluid overload at day three after ICU admission. Study Intervention: Patients admitted to the ICU with confirmed or suspected septic shock (Sepsis-3 definition) will be randomized (1:1) to either the intervention or standard of care. In the intervention arm, patients are managed according to the REDUCE fluid management protocol during resuscitation and de-resuscitation.

Conditions

• Septic Shock

Interventions

Type	Name	Description
OTHER	Fluid management according to the REDUCE Fluid Protocol	Fluid management according to the protocol will be guided by pre-defined clinical signs for impaired perfusion and fluid overload.
OTHER	Standard of care	Fluid resuscitation and de-resuscitation will be managed according to the standard of care

Timeline

• Start date: 2021-07-19
• Primary completion: 2025-02-10
• Completion: 2025-05-07
• First posted: 2021-06-18
• Last updated: 2025-04-06

Locations

4 sites across 1 country: Switzerland