Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
- Conditions
- Septic Shock
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1850
- 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.
- 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
- 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)
Related Research Topics
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Trial Locations
- Locations (12)
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
Stockholm South General Hospital (SÖS)
🇸🇪Stockholm, Sweden
University Hospital of Umeå
🇸🇪Umeå, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Scroll for more (2 remaining)Danderyd Hospital🇸🇪Danderyd, Sweden