Overview

Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients

Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Marie Kristine Jessen, MD
Collaborators:
Aarhus University Hospital
Randers Regional Hospital
University of Aarhus
Viborg Regional Hospital
Criteria
Inclusion Criteria: All of the below must be fulfilled:

1. Unplanned emergency department admission

2. Age ≥ 18 years

3. Sepsis defined as

1. suspected infection by the treating clinician AND

2. blood cultures drawn AND

3. IV antibiotics administered or planned AND

4. An infection related increase of SOFA*-score ≥ 2 from baseline

4. Expected hospital stay > 24 hours as deemed by treating clinician

- Sequential Organ Failure Assessment (SOFA) Score

Further more the patient must fulfill criteria for enrollment in an acute study according
to Danish law

Exclusion Criteria: We will exclude patients fulfilling any of following exclusion
criteria:

1. ≥ 500 ml of fluids given prior to randomization

2. Invasively ventilated or vasopressors initiated at the time of screening

3. Known or suspected severe bleeding judged by the treating clinician

4. Known or suspected pregnancy (women aged <45 years will have a pregnancy test
performed before enrollment)

5. Prior enrollment in the trial

6. Patients, who the clinician expect not to survive the next 24-hours