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

Not Applicable

Recruiting

• Conditions: Septic Shock
• Interventions: Other: Protocolised reduction of non-resuscitation fluids; Other: Usual care

• Registration Number: NCT06140147
• Lead Sponsor: Region Skane

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-18
• Study Start: 2023-11-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-01-31
• Primary Completion: 2027-12-31
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1850

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocolised reduction of non-resuscitation fluids	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.
Usual Care	Usual care	Participants receive non-resuscitation fluids according to local routines.

Primary Outcome Measures

Name	Time	Method
Mortality	90 days after inclusion	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	6 months after inclusion	Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)
Complications in the ICU	From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days	Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury.
Mechanical ventilation-free days	Within 90 days after inclusion	Mechanical ventilation-free days
Cognitive function	6 months after inclusion	Cognitive function measured using the Montreal Cognitive Assessment (MoCA)

Trial Locations

Locations (12)

Stockholm South General Hospital (SÖS); 🇸🇪 Stockholm, Sweden

University Hospital of Umeå; 🇸🇪 Umeå, Sweden

Danderyd Hospital; 🇸🇪 Danderyd, Sweden

Falun Hospital; 🇸🇪 Falun, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Halmstad Hospital; 🇸🇪 Halmstad, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Skåne University Hospital, Lund; 🇸🇪 Lund, Sweden

Skåne University Hospital, Malmö; 🇸🇪 Malmö, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Varberg Hospital; 🇸🇪 Varberg, Sweden

Östersund Hospital; 🇸🇪 Östersund, Sweden