Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT05076435
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05076435
Study Brief:
Protocol Section:
NCT05076435