Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled,
feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis
allocated to two different IV fluid regimens enrolled at three emergency departments in
Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume
within 24 hours and key secondary outcomes include protocol violations, total fluids
(intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day
mortality.
Phase:
Phase 2
Details
Lead Sponsor:
Marie Kristine Jessen, MD
Collaborators:
Aarhus University Hospital Randers Regional Hospital University of Aarhus Viborg Regional Hospital