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

Region Skane23 sites in 3 countries1,850 target enrollmentNovember 27, 2023

ConditionsSeptic Shock

InterventionsProtocolised reduction of non-resuscitation fluids Usual care

Overview

Phase: Not Applicable
Intervention: Protocolised reduction of non-resuscitation fluids
Conditions: Septic Shock
Sponsor: Region Skane
Enrollment: 1850
Locations: 23
Primary Endpoint: Mortality
Status: Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

November 27, 2023

End Date

July 1, 2028

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Region Skane

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Protocolised reduction of non-resuscitation fluids

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.

Intervention: Protocolised reduction of non-resuscitation fluids

Usual Care

Participants receive non-resuscitation fluids according to local routines.

Intervention: Usual care

Outcomes

Primary Outcomes

Mortality

Time Frame: 90 days after inclusion

All-cause mortality

Secondary Outcomes

Health-Related Quality of Life(6 months after inclusion)
Complications in the ICU(From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days)
Mechanical ventilation-free days(Within 90 days after inclusion)
Cognitive function(6 months after inclusion)