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Early Weight-Based Aggressive vs. Non-Aggressive Goal-Directed Fluid Resuscitation in the Early Phase of Acute Pancreatitis: An Open-Label Multicenter Randomized Controlled Trial (The WATERFALL Trial), Design, and Rationale
- Source :
- Frontiers in Medicine, Vol 7 (2020), Frontiers in Medicine
- Publication Year :
- 2020
- Publisher :
- Frontiers Media S.A., 2020.
-
Abstract
- Treatment options are limited for acute pancreatitis (AP). Early aggressive fluid resuscitation (AFR) has been widely considered beneficial because of theoretical improvement in end-organ perfusion, including the pancreas and gut, with pancreatic necrosis and bacterial translocation as consequences of ischemia. There is scarce direct evidence for its association to improved outcomes. Furthermore, it has been described that AFR may be associated with poor outcomes in severe AP. WATERFALL is an investigator-initiated international multicenter open-label randomized controlled trial comparing AFR vs. moderate fluid resuscitation (MFR) in AP. The main outcome variable will be the incidence of moderate to severe AP (a clinically relevant outcome that has been validated). Aggressive fluid resuscitation will consist in lactated Ringer solution (LR) 20-mL/kg bolus (administered over 2 h) followed by LR 3 mL/kg per hour. Patients randomized to MFR will receive an LR bolus 10 mL/kg in case of hypovolemia or no bolus in patients with normal volemia, followed by LR 1.5 mL/kg per hour. The patients will be assessed at 3 (±1), 12 (±4), 24 (±4), 48 (±4), and 72 (±4) h from recruitment, and fluid resuscitation will be adjusted to the patient's clinical and analytical status according to a protocol. Based on a prospective multicenter study, the incidence of moderate to severe AP is 35%. Sample sizes of 372 patients per group (overall 744) achieve 80% power to detect a difference in the incidence of moderate to severe AP of 10%, at a significance level (α) of 0.05 using a two-sided z-test, assuming a 10% dropout rate. These results assume that three sequential tests are made using the O'Brien–Fleming spending function to determine the test boundaries.
- Subjects :
- Resuscitation
randomized controlled (clinical) trial
fluid resuscitation
law.invention
fluid therapy
Study Protocol
03 medical and health sciences
0302 clinical medicine
Bolus (medicine)
Randomized controlled trial
law
Hypovolemia
Statistical significance
medicine
lcsh:R5-920
business.industry
ringer lactate
General Medicine
medicine.disease
Sample size determination
030220 oncology & carcinogenesis
Anesthesia
Medicine
Acute pancreatitis
030211 gastroenterology & hepatology
acute pancreatitis (AP)
medicine.symptom
business
lcsh:Medicine (General)
Perfusion
Subjects
Details
- Language :
- English
- Volume :
- 7
- Database :
- OpenAIRE
- Journal :
- Frontiers in Medicine
- Accession number :
- edsair.doi.dedup.....456f733843ef72ea85988119253557b7