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RECRUITING
NCT06140147
NA

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

Sponsor: Region Skane

View on ClinicalTrials.gov

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

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

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