Status:
TERMINATED
Aggressive Versus Non-aggressive Goal-directed Fluid Resuscitation in Acute Pancreatitis
Lead Sponsor:
Enrique de-Madaria
Collaborating Sponsors:
Instituto de Salud Carlos III
Asociación Española de Gastroenterología
Conditions:
Acute Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
WATERFALL is an investigator-initiated international multicenter open-label randomized clinical trial comparing aggressive versus moderate fluid resuscitation in acute pancreatitis. The main outcome v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2021
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT04381169
Start Date
May 28 2020
End Date
September 25 2021
Last Update
March 21 2022
Active Locations (2)
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1
Alicante
Alicante, Spain, 03010
2
Hospital General Universitario de Alicante
Alicante, Spain, 03550