Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

Region Skane

Status: Completed

Conditions: Shock, Septic

Treatments: Other: Protocolised reduction of non-resuscitation fluids; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05249088

REDUSE feasibility trial

Details and patient eligibility

About

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (≥ 18 years of age)
• Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
• Inclusion within 12 hours after ICU admission.

Exclusion criteria

• Confirmed or suspected pregnancy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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98 participants in 2 patient groups

Protocolised reduction of non-resuscitation fluids

Experimental group

Description:

Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.

Treatment:

Other: Protocolised reduction of non-resuscitation fluids

Usual Care

Other group

Description:

Participants receive non-resuscitation fluids according to local routines.

Treatment:

Other: Usual care