Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial
- Conditions
- Shock, Septic
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 98
- 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.
- Confirmed or suspected pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Sahlgrenska University Hospital🇸🇪Gothenburg, Sweden