Clinical trial NCT06140147: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Official title: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 1850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

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

Primary outcomes:
measure: Mortality
timeFrame: 90 days after inclusion
Secondary outcomes:
measure: Complications in the ICU
timeFrame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: Mechanical ventilation-free days
timeFrame: Within 90 days after inclusion
measure: Cognitive function
timeFrame: 6 months after inclusion
measure: Health-Related Quality of Life
timeFrame: 6 months after inclusion
Other outcomes:
measure: Hospital-free days
timeFrame: Within 90 days after inclusion
measure: Vasopressor-free days
timeFrame: Within 90 days after inclusion
measure: Renal replacement therapy (RRT)-free days
timeFrame: Within 90 days after inclusion
measure: Major adverse kidney events (MAKE)
timeFrame: 90 days after inclusion
measure: Cumulative dose of diuretics
timeFrame: 5 days after inclusion
measure: Glasgow Outcome Scale Extended (GOSE) score
timeFrame: 6 months after inclusion
measure: Health-Related Quality of Life
timeFrame: 6 months after inclusion
measure: Health and disability
timeFrame: 6 months after inclusion
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 6 months after inclusion
measure: Mortality
timeFrame: 12 months after inclusion
measure: Number of days in the ICU
timeFrame: Within 90 days of inclusion
measure: Hypoglycaemia
timeFrame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: Hypernatremia
timeFrame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: Acid-base disturbances
timeFrame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
measure: Central venous catheter-related complications
timeFrame: From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Locations:
city: Danderyd
country: Sweden
facility: Danderyd Hospital
city: Falun
country: Sweden
facility: Falun Hospital
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Halmstad
country: Sweden
facility: Halmstad Hospital
city: Helsingborg
country: Sweden
facility: Helsingborg Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital, Lund
city: Malmö
country: Sweden
facility: Skåne University Hospital, Malmö
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital (SÖS)
city: Umeå
country: Sweden
facility: University Hospital of Umeå
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Varberg
country: Sweden
facility: Varberg Hospital
city: Östersund
country: Sweden
facility: Östersund Hospital
Study officials:
affiliation: Region Skåne
name: Peter Bentzer
role: PRINCIPAL_INVESTIGATOR
References: