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NCT Number: NCT04931485

Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Fluid management according to the REDUCE Fluid Protocol

Other

Fluid management according to the protocol will be guided by pre-defined clinical signs for impaired perfusion and fluid overload.

Other names: REDUCE protocol

Standard of care

Other

Fluid resuscitation and de-resuscitation will be managed according to the standard of care

Primary outcomes

  1. Proportion of patient with a negative fluid balance on day 3

    Time frame: Up to day 3 after ICU admission

    Proportion of patients with a negative cumulative fluid balance on day 3

Secondary outcomes

  1. Number of patients with fluid overload at day 3 and ICU discharge

    Time frame: From hospital admission to the end of ICU stay, on average after 7 days

    Fluid overload as defined as ((input-output)/admission weight)*100

  2. Feasibility of the REDUCE fluid protocol

    Time frame: From randomisation until the end of ICU stay, on average after 7 days

    Number of REDUCE fluid protocol violations

  3. Incidence of ischemic events and severe AKI

    Time frame: Ischemic events and AKI: From randomisation until the end of ICU stay (on average after 7 days), and at day 30; electrolyte and acid-base/medication associated safety endpoints: during ICU stay (on average 7 days)

    Number of patients with:ischaemic events, severe AKI (AKIN stage 2 or more); respectively episodes of: severe hypernatremia (sodium >/= 155mmol/l), severe hypokalemia (< 3.0 mmol/l), severe metabolic alkalosis (pH >/= 7.55, bicarbonate >/= 35 mmol/l), anaphylactic reaction to diuretic drug

  4. Ventilator-free days at day 30

    Time frame: Up to 30 days after randomisation

    Ventilator free days up to day 30

  5. Vasopressor-free days at day 30

    Time frame: Up to 30 days after randomisation

    Vasopressor free days up to day 30

  6. Renal replacement therapy

    Time frame: Up to 90 days after randomisation

    Need for and time on renal replacement therapy

  7. Number of patients with need for renal replacement at 90days

    Time frame: Up to 90 days after randomisation

    Number of patients with on-going need for renal replacement at 90days

  8. All-cause mortality

    Time frame: Up to 90 days after randomisation

    At 30days and 90 days after randomization

Other outcomes

  1. Daily cumulative fluid balance up to day 7

    Time frame: Throughout the ICU stay, on average 7 days

    Cumulative fluid balance is total input - total output

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: REDUCE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 18, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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