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 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT05453695
Eligibility Criteria:
Inclusion Criteria:
1. Age of ≥18 years
2. Admitted to the ICU in the last 48 hours
3. Suspected or proven infection as the admitting diagnosis
4. A sequential (sepsis) organ function assessment (SOFA) score of ≥2 above baseline
5. Expected to remain in the ICU for ≥ 72 hours
Exclusion Criteria:
1. No consent/inability to obtain consent from a substitute decision-maker
2. Have other forms of clinically apparent shock, including cardiogenic, obstructive (massive pulmonary embolism, cardiac tamponade, tension pneumothorax), hemorrhagic, neurogenic, or anaphylactic shock
3. Have a significant risk of bleeding as evidenced by one of the following:
* Surgery requiring general or spinal anesthesia within 24 hours before enrolment
* The potential need for surgery in the next 24 hours
* Evidence of active bleeding
* A history of severe head trauma requiring hospitalization
* Intracranial surgery, or stroke within three months before the study
* Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system
* A history of congenital bleeding diatheses
* Gastrointestinal bleeding within five weeks before the study unless corrective surgery had been performed
* Trauma is considered to increase the risk of bleeding
* Presence of an epidural catheter
* Need for therapeutic anticoagulation
4. Receiving DNase I by inhalation
5. Terminal illness with a life expectancy of fewer than three months
6. Pregnant and/or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05453695
Study Brief:
Protocol Section:
NCT05453695