Status:
COMPLETED
Guided Fluid-balance Optimization With Mini-fluid chALlenge During Septic Shock
Lead Sponsor:
University Hospital, Brest
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Many observational studies have highlighted an independent association between fluid overload and clinical outcomes during septic shock. To optimize fluid balance, clinician has several options to con...
Detailed Description
GOAL study is a stepped wedge cluster-randomized trial. Centers will switch randomly from the control to the intervention at regular intervals: * Control periods: Patients receive a usual optimizatio...
Eligibility Criteria
Inclusion
- Adult patient (Age \> 18 years)
- Admitted in ICU for less than 3 days.
- Abdominal (excepted urinary tract infection) or pulmonary related septic shock, defined by SEPSIS III criteria diagnosed within less than 12 hours.
- Written consent or oral by the patient (and/or consent signed by the next of skin)
- Patient has social security affiliation or who beneficiary of such social security
Exclusion
- Patient with life expectancy inferior to 24 hours at the time of inclusion.
- Cardiac arrest
- Allergy to albumin
- Pregnancy
- Traumatic brain injury
- Limitation of invasive therapeutics, palliative care
- Patient under guardianship or curatorship
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2024
Estimated Enrollment :
535 Patients enrolled
Trial Details
Trial ID
NCT03461900
Start Date
June 4 2019
End Date
January 8 2024
Last Update
September 19 2025
Active Locations (18)
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1
Angers university hospital
Angers, France
2
Besançon university hospital
Besançon, France
3
Brest university hospital
Brest, France, 29200
4
Brest university hospital
Brest, France