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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT03334006
Eligibility Criteria:
Inclusion Criteria:
1. The patient is diagnosed with secondary or quaternary peritonitis
2. The time of the surgical infectious source control is within 6 hours of indication (defined as date and time of registration for surgical or minimal invasive procedure).
3. Sepsis and / or septic shock (according to the current sepsis guideline of the German Sepsis Society).
4. SOFA Score ≥ 8
5. The concentration of IL-6 is ≥ 1000 pg / ml
6. Treatment with antibiotics is started within 12 hours of admission to the Intensive Care Unit
7. The informed consent form has been signed by the patient and / or by his legal representative (such as his spouse, an health care proxy authorized or a legal representative) or by a consultant physician
Exclusion criteria
1. Patients with a life expectancy of less than 90 days due to medical conditions unrelated to peritonitis nor with sepsis and / or septic shock.
2. For female patients: The patient is pregnant or breastfeeding.
3. The patient is a minor (\< 18 years of age).
4. The patient has known chronic renal dysfunction requiring dialysis (creatinine ≥ 3.4 mg / dl or creatinine clearance ≤ 30 mL/min/1.73 m²).
5. The patient has acute, primarily non-infectious pancreatitis or mediastinitis.
6. The patient has a BMI \> 40.
7. The patient has any contraindication to study drug.
8. The patient has participated in another clinical trial within the last 30 days.
9. The patient is in a dependent or employment relationship with the sponsor or investigator.
10. The patient is institutionalized by court or government order.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03334006
Study Brief:
Protocol Section:
NCT03334006