Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients (REDUSE)

Region Skane

Status: Enrolling

Conditions: Septic Shock

Treatments: Other: Protocolised reduction of non-resuscitation fluids; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06140147

REDUSE

Details and patient eligibility

About

The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.

Enrollment: 1,850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥ 18 years of age)
• Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation [> 1L within 12 h of screening]) and need for vasopressors at the time of screening.

Exclusion criteria

• Confirmed or suspected pregnancy
• Previous inclusion in the trial
• Screened more than 12 hours after ICU admission

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,850 participants in 2 patient groups

Protocolised reduction of non-resuscitation fluids

Experimental group

Description:

Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.

Treatment:

Other: Protocolised reduction of non-resuscitation fluids

Usual Care

Other group

Description:

Participants receive non-resuscitation fluids according to local routines.

Treatment:

Other: Usual care