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Protocolised Early De-Resuscitation in Septic Shock (REDUCE)
Sponsor: Insel Gruppe AG, University Hospital Bern
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
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.
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