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 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT07249151
Eligibility Criteria:
Inclusion Criteria:
Patients will be eligible for enrollment if they meet all of the following conditions:
1. Age between 18 and 80 years at the time of presentation.
2. Presentation to the emergency department (ED) for acute medical evaluation.
3. Completion of at least one documented Early Warning Score (EWS) assessment upon ED admission or during the ED stay.
Exclusion Criteria:
Patients will be excluded if they meet any of the following criteria:
1. Do-not-resuscitate (DNR) orders or enrollment in a palliative/comfort care pathway at the time of presentation.
2. Cardiac arrest upon arrival to the ED (unresponsive, pulseless, requiring resuscitation without return of spontaneous circulation).
3. Transfer out of the hospital (to another institution or to the operating room for immediate surgery) within 24 hours of ED admission.
4. History of major cardiac surgery (e.g., coronary artery bypass grafting, valve replacement) or heart transplantation, as these conditions may alter baseline hemodynamics and limit EWS applicability.
5. Severe chronic organ dysfunction, including:
End-stage renal disease requiring maintenance dialysis; Severe hepatic insufficiency (Child-Pugh class C or equivalent); Advanced heart failure (New York Heart Association class IV).
6. Known allergy or contraindication to iodinated contrast media (if relevant laboratory or imaging assessments are required for outcome evaluation).
7. Pregnancy, due to altered physiological parameters and ethical considerations.
8. Incomplete or missing clinical records, preventing calculation of EWS or confirmation of study endpoints.
9. Duplicate enrollment due to repeated ED visits or readmissions during the study period (only the first eligible admission will be included).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07249151
Study Brief:
Protocol Section:
NCT07249151