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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04381169
Eligibility Criteria:
Inclusion Criteria:
* Patients age greater or equal to 18 presenting to one of the collaborating centers
* Diagnosis of acute pancreatitis according to the revised Atlanta classification which requires 2 of the following 3 criteria: A) Typical abdominal pain; B) Increase in serum amylase or lipase levels higher than 3 times the upper limit of normality; and C) Signs of AP in imaging.
Exclusion Criteria:
* Uncontrolled arterial hypertension (systolic blood pressure \>180 and/or diastolic blood pressure 100 mmHg);
* New York Heart Association Class II hear failure (slight limitation of physical activity; fatigue, palpitations or dyspnea with ordinal physical activity) or worse, or ejection fraction\<50% in the last echocardiography;
* Decompensated cirrhosis (Child's Class B or C);
* Hyper or hyponatremia (\<135 or \>145 mEq/l);
* Hyperkalemia (\>5 mEq/l);
* Hypercalcemia (albumin or protein-corrected calcium\>10.5 mg/dl);
* Chronic kidney failure (basal glomerular filtration rate \<60 mL/min/1.73m2);
* Clinical signs or symptoms of volume overload or heart failure at recruitment (dyspnea, peripheral edema, pulmonary rales, or evident increased jugular ingurgitation at 45º);
* Shock or respiratory failure according to the revised Atlanta classification at recruitment (non-fluid responding systolic blood pressure\< 90 mmHg, PaO2/FIO2≤300 mmHg);
* Time from pain onset to arrival to emergency room \>24h;
* Time from confirmation of pancreatitis to randomization \>8h;
* Severe comorbidity associated with an estimated life expectancy \<1 year;
* Confirmed chronic pancreatitis (in case of recurrent alcoholic pancreatitis a recent (\<6 months) CT scan/MRI or endoscopic ultrasound is needed to rule out chronic pancreatitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04381169
Study Brief:
Protocol Section:
NCT04381169