Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial

Region Skane8 sites in 1 country98 target enrollmentMarch 1, 2022

ConditionsShock, Septic

Overview

Phase: N/A
Intervention: Not specified
Conditions: Shock, Septic
Sponsor: Region Skane
Enrollment: 98
Locations: 8
Primary Endpoint: Difference in fluid administration
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

March 27, 2023

Last Updated

2 years 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: 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

Outcomes

Primary Outcomes

Difference in fluid administration

Time Frame: Within the first three days after inclusion (days 0-3)

Total difference in litres of administered fluids between groups

Secondary Outcomes

Inclusion of eligible patients(During inclusion)
Protocol violations(Within 90 days after inclusion)
Proportion of participants with sufficient clinical outcome data(Within 90 days after inclusion)
Proportion of participants assessed by EQ5D-5L and MoCA(6 months after inclusion)