Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

Not Applicable

Completed

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

• Registration Number: NCT05249088
• Lead Sponsor: Region Skane

Brief Summary

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-18
• Study First Posted: 2022-02-21
• Study Start: 2022-03-01
• Primary Completion: 2022-09-13
• Study Completion: 2023-03-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Adult (≥ 18 years of age)
• Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
• Inclusion within 12 hours after ICU admission.

Exclusion Criteria

• Confirmed or suspected pregnancy

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
Difference in fluid administration	Within the first three days after inclusion (days 0-3)	Total difference in litres of administered fluids between groups

Secondary Outcome Measures

Name	Time	Method
Inclusion of eligible patients	During inclusion	Fraction of all eligible patients who were randomised and consented
Protocol violations	Within 90 days after inclusion	Fraction of patients experiencing at least one protocol violation
Proportion of participants with sufficient clinical outcome data	Within 90 days after inclusion	Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia)
Proportion of participants assessed by EQ5D-5L and MoCA	6 months after inclusion	Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA)

Trial Locations

Locations (8)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden

Halmstad Hospital; 🇸🇪 Halmstad, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Kristianstad Hospital; 🇸🇪 Kristianstad, Sweden

Skåne University Hospital, Lund; 🇸🇪 Lund, Sweden

Skåne University Hospital, Malmö; 🇸🇪 Malmö, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Östersund Hospital; 🇸🇪 Östersund, Sweden