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ACTIVE NOT RECRUITING
NCT04931485
NA

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2021-07-19

Completion Date

2025-05-07

Last Updated

2025-04-06

Healthy Volunteers

No

Conditions

Interventions

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

Locations (4)

University Hospital Basel

Basel, Switzerland

University Hospital Bern, Inselspital

Bern, Switzerland

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland