RecruitingNot ApplicableNCT06140147

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


Sponsor

Region Skane

Enrollment

1,850 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Protocolised reduction of non-resuscitation fluids and Usual care for people with septic shock. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERProtocolised 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)

OTHERUsual 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

Malmö, 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

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NCT06140147


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