Status:

RECRUITING

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

Lead Sponsor:

Region Skane

Conditions:

Septic Shock

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 Criteria

Inclusion

  • Adult (≥ 18 years of age)
  • Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation \[\> 1L within 12 h of screening\]) and need for vasopressors at the time of screening.

Exclusion

  • Confirmed or suspected pregnancy
  • Previous inclusion in the trial
  • Screened more than 12 hours after ICU admission

Key Trial Info

Start Date :

November 27 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2028

Estimated Enrollment :

1850 Patients enrolled

Trial Details

Trial ID

NCT06140147

Start Date

November 27 2023

End Date

July 1 2028

Last Update

December 16 2025

Active Locations (20)

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Page 1 of 5 (20 locations)

1

Helsinki University Hospital

Helsinki, Finland

2

Tampere University Hospital

Tampere, Finland

3

Danderyd Hospital

Danderyd, Sweden

4

Malar Hospital

Eskilstuna, Sweden