ormal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial
- Conditions
- Acute pancreatitisMedDRA version: 20.0Level: PTClassification code: 10033647Term: Pancreatitis acute Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-509879-16-00
- Lead Sponsor
- Hospital General Universitario Dr. Balmis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Patient is 18 years or older, Diagnosis of acute pancreatitis according to the revision of the Atlanta classification (Banks et al, Gut 2013), which requires at least two of the following three criteria: A) typical abdominal pain, B) increase in serum amylase or lipase levels higher than three times the upper limit of normality, and C) signs of acute pancreatitis in imaging, Signature of informed consent
New York Heart Association class II heart failure (slight limitation of physical activity; fatigue, palpitations, or dyspnea with ordinal physical activity) or worse, or ejection fraction <50% in the last echocardiography, Chronic pancreatitis defined by a Wirsung duct =4mm and/or pancreatic calcifications, 11.More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode), 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 or 2.62 mmol/L), Criteria for moderately severe or severe acute pancreatitis (revision of the Atlanta classification, Banks et al, Gut 2013) at recruitment: any of the following: A) presence of creatinine =1.9 mg/dL or =170 mmol/l, B) PaO2/FiO2=300, C) systolic blood pressure <90 mmHg despite initial fluid resuscitation, D) presence of local complications (acute peripancreatic fluid collections, acute necrotic collection, pseudocyst, walled-off necrosis, gastric outlet dysfunction, splenic or portal vein thrombosis, or colonic necrosis), E) exacerbation of previous comorbidity such as coronary artery disease or chronic lung disease, precipitated by the acute pancreatitis, 7.Signs of volume overload or heart failure at recruitment (peripheral edema, pulmonary rales, or increased jugular ingurgitation at 45º), Time from pain onset to arrival to emergency room >24 h, Time from confirmation of pancreatitis to randomization >8 h
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to investigate the effect of lactated Ringer solution compared to normal saline on the severity and safety of acute pancreatitis. The main efficacy endpoint is the frequency of moderately severe to severe acute pancreatitis according to the revision of the Atlanta classification. The main safety endpoint is a compound variable: fluid overload or acute kidney injury or hyperkalemia or hypercalcemia or acidosis.;Secondary Objective: The secondary objectives of the trial are to investigate the effect of lactated Ringer solution compared to normal saline on the secondary efficacy and safety endpoints.;Primary end point(s): The primary outcome will be moderately severe to severe AP, according to the RAC. (Atlanta classification) within the first 30 days after randomization.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Local complications (specific complications will be also recorded) Necrotizing pancreatitis SIRS Number of SIRS criteria PAN-PROMISE symptom scale Time to oral refeeding Invasive treatment Nutritional support Intensive care unit admission Exacerbation of coexisting condition Any organ failure Persistent organ failure Shock Respiratory failure Kidney failure Death Hospital stay C-reactive protein