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:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT03085758
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent by patient or legal representative (according to country - specific regulations)
2. Male and female patient, age ≥ 18 years
3. Body weight 50 kg - 120 kg
4. Bio-ADM concentration \> 70 pg/ml
5. Patient with early septic shock (start of vasopressor therapy \< 12 hours)
6. Women of childbearing potential must have a negative serum or urine pregnancy test before randomization
7. Highly effective method of contraception must be maintained for 6 months after study start by women of childbearing potential and sexually active men.
8. No care limitation
Exclusion Criteria:
1. Moribund
2. Pre-existing unstable condition (e.g. a recent cerebral hemorrhage or infarct, a recent acute unstable myocardial infarction (all \< 3 months), congestive heart failure - New York Heart Association (NYHA) Class IV
3. Patients that required cardiopulmonary resuscitation in the last 4 weeks prior to evaluation for enrollment
4. Severe Chronic Obstructive Pulmonary Disease (COPD) with chronic oxygen need at home (GOLD IV)
5. Any organ or bone marrow transplant within the past 24 weeks
6. Uncontrolled serious hemorrhage (≥ 2 units of blood / platelets in the previous 24 hrs.). Patients may be considered for enrollment if bleeding has stopped and patient is otherwise qualified
7. Uncontrolled hematological / oncological malignancies
8. Absolute neutropenia \< 500 per µL
9. Severe chronic liver disease (Child-Pugh C)
10. Systemic fungal infection or active tuberculosis
11. Neuromuscular disorders that impact breathing / spontaneous ventilation
12. Burns \> 30% of body surface
13. Plasmapheresis
14. Breastfeeding women
15. Participation in a clinical trial involving another investigational drug within 4 weeks prior to inclusion
16. Unwilling or unable to be fully evaluated for all follow-up visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03085758
Study Brief:
Protocol Section:
NCT03085758