MedTrace Logo

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

NCT04931485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Anna S Messmer, MD · Department of Intensive Care, Inselspital, Bern University Hospital, Bern, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-19
Primary Completion
2025-02-10
Completion
2025-05-07

Countries

  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04931485 on ClinicalTrials.gov