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Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Sponsor: Region Skane
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1850
Start Date
2023-11-27
Completion Date
2028-07-01
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Protocolised reduction of non-resuscitation fluids
Maintenance fluid: discontinued if cumulative fluid balance is positive and patient is not dehydrated Intravenous fluid and enteral water: as needed to correct electrolyte disturbances Enteral nutrition (at least 2 kcal/ml): per local practice Glucose (conc. ≥20%, dose ≤1g/kg/day): may be used as nutrition if enteral feeding not tolerated starting 72h after inclusion. May be started earlier in patients with insulin-dependent diabetes or risk of hypoglycemia per local practice Parenteral nutrition: per local practice Intravenous medications: concentrated according to a predefined protocol Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids so the total dose of fluids covers the daily need of water (about 1ml/kg/h)
Usual care
Participants receive non-resuscitation fluids according to local routines, with the following stipulations: Maintenance fluids (crystalloids and/or glucose and/or enteral water): given at a dose of 1 ml/kg/h unless local protocol states otherwise Glucose: used at maximal concentration of 10% unless local protocol states otherwise. Medications: concentrated per local protocol
Locations (22)
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Danderyd Hospital
Danderyd, Sweden
Malar Hospital
Eskilstuna, Sweden
Falun Hospital
Falun, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Östra Hospital
Gothenburg, Sweden
Halmstad Hospital
Halmstad, Sweden
Helsingborg Hospital
Helsingborg, Sweden
Skåne University Hospital, Lund
Lund, Sweden
Skåne University Hospital, Malmö
Malmo, Sweden
Norrtälje Hospital
Norrtälje, Sweden
Örebro University Hospital
Örebro, Sweden
Östersund Hospital
Östersund, Sweden
Södertälje Hospital
Södertälje, Sweden
Stockholm South General Hospital (SÖS)
Stockholm, Sweden
University Hospital of Umeå
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Varberg Hospital
Varberg, Sweden
University Hospital of Wales
Cardiff, United Kingdom