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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT07267169
Eligibility Criteria:
Inclusion Criteria:
* ≤ 5 days from the onset of acute pancreatitis
* Acute pancreatitis of moderate or severe according to the Atlanta classification (2012)
* Acute pancreatitis confirmed by tomography. Modified CTSI Pancreatitis Severity Index Score ≥ 4 points
* APACHE II \> 8
* ≥ 2 points on the Sequential Organ Failure Assessment (SOFA) scale and/or ≥ 2 criteria of Systemic Inflammatory Response Syndrome (SIRS):
* Body temperature ≥ 38 °C or ≤ 36 °C
* Heart rate ≥ 90/min
* Respiratory rate ≥ 20/min or hyperventilation with PaCO₂ ≤ 32 mmHg
* Leukocytosis (≥ 12,000/μl) or leukopenia (≤ 4,000/μl) or left shift of leukocyte formula
Exclusion Criteria:
* SOFA score \> 12 points
* Presence of an uncontrolled surgical infection focus
* Development of septic complications - signs of infection
* Acute pancreatitis as an exacerbation of chronic pancreatitis
* Blood triglyceride level \> 1000 mg/dL (11.2 mmol/L)
* Liver cirrhosis (\> 6 points by Child-Pugh classification)
* Unresolved biliary hypertension syndrome
* BMI ≥ 40
* Dementia
* Chronic kidney disease stage 4-5
* Acute pulmonary embolism confirmed by CT
* Acute myocardial infarction within the last 4 weeks
* Acute cerebrovascular accident
* Severe congestive heart failure
* Uncontrolled bleeding (acute blood loss within the last 24 hours)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07267169
Study Brief:
Protocol Section:
NCT07267169