NCT06140147

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,850 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-27
• Primary completion: 2027-12-31
• Completion: 2028-07-01
• First posted: 2023-11-18
• Last updated: 2026-04-01

Locations

22 sites across 3 countries: Finland, Sweden, United Kingdom