Protocolised Early De-Resuscitation in Septic Shock (REDUCE)

Insel Gruppe AG, University Hospital Bern

Status: Active, not recruiting

Conditions: Septic Shock

Treatments: Other: Standard of care; Other: Fluid management according to the REDUCE Fluid Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04931485

REDUCE

Details and patient eligibility

About

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.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

Intervention: REDUCE Protocol

Experimental group

Description:

Fluid resuscitation and de-resuscitation is based on the REDUCE fluid management protocol.

Treatment:

Other: Fluid management according to the REDUCE Fluid Protocol

Standard of Care

Active Comparator group

Description:

Fluid resuscitation and de-resuscitation according to the standard of care

Treatment:

Other: Standard of care