Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

NARecruitingINTERVENTIONAL
Enrollment

1,850

Participants

Timeline

Start Date

November 27, 2023

Primary Completion Date

December 31, 2027

Study Completion Date

July 1, 2028

Conditions
Septic Shock
Interventions
OTHER

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)

OTHER

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"

Trial Locations (17)

Unknown

NOT_YET_RECRUITING

Helsinki University Hospital, Helsinki

RECRUITING

Danderyd Hospital, Danderyd

RECRUITING

Falun Hospital, Falun

RECRUITING

Sahlgrenska University Hospital, Gothenburg

RECRUITING

Halmstad Hospital, Halmstad

RECRUITING

Helsingborg Hospital, Helsingborg

RECRUITING

Skåne University Hospital, Lund, Lund

RECRUITING

Skåne University Hospital, Malmö, Malmo

NOT_YET_RECRUITING

Norrtälje Hospital, Norrtälje

RECRUITING

Örebro University Hospital, Örebro

RECRUITING

Östersund Hospital, Östersund

NOT_YET_RECRUITING

Södertälje Hospital, Södertälje

NOT_YET_RECRUITING

Stockholm South General Hospital (SÖS), Stockholm

RECRUITING

University Hospital of Umeå, Umeå

RECRUITING

Uppsala University Hospital, Uppsala

RECRUITING

Varberg Hospital, Varberg

NOT_YET_RECRUITING

University Hospital of Wales, Cardiff

All Listed Sponsors
lead

Region Skane

OTHER