Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

Last updated: April 3, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

Fluid management according to the REDUCE Fluid Protocol

Standard of care

Clinical Study ID

NCT04931485
REDUCE
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients admitted to ICU with the diagnosis of septic shock as defined according tothe Sepsis-3 criteria (suspected or confirmed infection AND vasopressor/inotropeongoing to maintain MAP ≥ 65 mmHg AND Lactate ≥ 2 mmol/l in the last 6 hours

Exclusion

Exclusion Criteria:

  • Age <18 years

  • Septic shock for more than 12 hours at the time of screening

  • Acute burn injury >/= 10% of the body surface area

  • Known pregnancy or lactating women

  • Consent not obtainable due to national legislation

  • Patients on chronic dialysis

  • Patients that are known to be allergic to furosemide or metolazone

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Fluid management according to the REDUCE Fluid Protocol
Phase:
Study Start date:
July 19, 2021
Estimated Completion Date:
May 07, 2025

Connect with a study center

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

  • University Hospital Bern, Inselspital

    Bern, 3010
    Switzerland

    Site Not Available

  • Cantonal Hospital St. Gallen

    St. Gallen, 9000
    Switzerland

    Site Not Available

  • Kantonsspital Winterthur

    Winterthur, 8400
    Switzerland

    Site Not Available

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