Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 98
- Locations
- 8
- Primary Endpoint
- Difference in fluid administration
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
The clinical team caring for participants will not be blinded due to nature of the intervention. The participants, their family and health personnel responsible for outcome assessment at follow-up will be blinded to the allocation of the intervention. The steering group, author group, trial statistician, outcome assessors, prognosticators, statisticians, and the trial coordinating team will be blinded to group allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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 (Other)
Usual Care
Participants receive non-resuscitation fluids according to local routines.
Intervention: Usual care (Other)
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)