WATERFALL trial: Aggressive fluid resuscitation in the initial phase of acute pancreatitis

Phase 1

• Conditions: Acute pancreatitis; MedDRA version: 20.0 Level: PT Classification code 10033647 Term: Pancreatitis acute System Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-000788-26-ES
• Lead Sponsor: Enrique de Madaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 700

Inclusion Criteria

adult (=18) patients with AP according to the revision of the Atlanta classification (RAC) (Banks et al, Gut 2013): at least 2 of the following 3 criteria: A) Typical abdominal pain, B) Increase in serum amylase or lypase levels higher than 3 times the upper limit of normality, and C) Signs of AP in imaging techniques (CT scan or MRI). This study requires signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

Exclusion Criteria

non-controlled arterial hypertension (>160 (Systolic BP) and/or 100 mmHg (diastolic BP), heart failure (New York Hear Association Class II-IV) or ejection fraction <50%, decompensated cirrhosis (Child’s Class B or C), Hyper or hyponatremia (<135 or >145 mEq/l), hyperpotassemia (>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 of volume overload (peripheral edema, pulmonary rales, and ascites), organ failure according to the RAC (Marshall=2), 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 and 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified