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

Effect of early weight-based aggressive versus non-aggressive goal-directed fluid resuscitation in the early phase of acute pancreatitis: an open-label multicenter randomized-controlled trial - Aggressive fluid resuscitation in the acute pancreatitis

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000788-26-ES

Enrollment

700

Registered

2019-04-30

Start date

2019-06-10

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute pancreatitis MedDRA version: 20.0 Level: PT Classification code 10033647 Term: Pancreatitis acute System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: FREEFLEX RINGER LACTATO Pharmaceutical Form: Solution for infusion INN or Proposed INN: lactated Ringer Solution CAS Number: 8026-79-7

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 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 145 mEq/l), hyperpotassemia (>5 mEq/l), hypercalcemia (albumin or protein-corrected calcium>10.5 mg/dl), chronic kidney failure (basal glomerular filtration rate 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).

Design outcomes

Primary

Measure	Time frame
Main Objective: to compare the effect of early aggressive fluid resuscitation versus a more restricted fluid resuscitation strategy in the incidence of moderate-to-severe AP;Primary end point(s): Incidence of moderate-to-severe AP according to the RAC;Timepoint(s) of evaluation of this end point: At hospital discharge; Secondary Objective: Secondary objectives: comparison with an aggressive fluidity versus a restrictive one in terms of: A) Incidence of local and systemic complications of acute pancreatitis. B) Safety of treatment: incidence of fluid overload, renal failure and hypotension. C) Hospital stay, need for ICU, stay in ICU D) Need for invasive treatment and nutritional support. E) Mortality	—

Measure

Time frame

Main Objective: to compare the effect of early aggressive fluid resuscitation versus a more restricted fluid resuscitation strategy in the incidence of moderate-to-severe AP;Primary end point(s): Incidence of moderate-to-severe AP according to the RAC;Timepoint(s) of evaluation of this end point: At hospital discharge; Secondary Objective: Secondary objectives: comparison with an aggressive fluidity versus a restrictive one in terms of: A) Incidence of local and systemic complications of acute pancreatitis. B) Safety of treatment: incidence of fluid overload, renal failure and hypotension. C) Hospital stay, need for ICU, stay in ICU D) Need for invasive treatment and nutritional support. E) Mortality

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: At hospital discharge;Secondary end point(s): combined variable mortality and / or persistent organic failure and / or pancreatic necrosis infection. Fluid overload, local complications (acute peripancreatic fluid collection, pancreatic and peripancreatic necrosis, pancreatic necrosis infection), organic and persistent failure, and hospitalization, hospital stay, stay in the ICU, need for organ failure. Need for nutritional support (enteral and / or parenteral nutrition).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: At hospital discharge;Secondary end point(s): combined variable mortality and / or persistent organic failure and / or pancreatic necrosis infection. Fluid overload, local complications (acute peripancreatic fluid collection, pancreatic and peripancreatic necrosis, pancreatic necrosis infection), organic and persistent failure, and hospitalization, hospital stay, stay in the ICU, need for organ failure. Need for nutritional support (enteral and / or parenteral nutrition).

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Countries

Chile, Colombia, Mexico, Paraguay, Spain

Contacts

Public ContactPancreatic Unit Coordinator

Servicio de Aparato Digestivo, Hospital General Universitario de Alicante

madaria@hotmail.com0034965933468

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026