Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation
NCT ID: NCT05781243
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
792 participants
INTERVENTIONAL
2023-06-19
2024-09-30
Brief Summary
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Methods: The WATERLAND trial is an international multicenter, open-label, parallel-group, randomized, controlled, superiority trial. Patients will be randomly assigned in a 1:1 ratio to receive LR versus NS-based fluid resuscitation for at least 48 hours. The primary outcome will be moderately severe or severe AP, according to the revision of the Atlanta classification. The secondary objectives of the WATERLAND trial are to determine the effect of LR versus NS fluid resuscitation on several efficacy and safety outcomes in patients with AP.
A total sample of 720 patients, 360 in the LR group and 360 in the NS group, will achieve 90% power to detect a difference between the group proportions of 10%, assuming that the frequency of moderately severe or severe AP in the LR group will be 17%. A loss to follow-up of 10% of patients is expected, so the total sample size will be 396 patients in each treatment arm (792 patients overall). The test statistic used is the two-sided Z test with pooled variance set at a 0.05 significance level.
Discussion: The WATERLAND study aims to improve the early management of AP. Fluid resuscitation is an inexpensive treatment available in any hospital center worldwide. If a better evolution of pancreatitis is demonstrated in one of the treatment arms, it would have important repercussions in the management of this frequent disease.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lactated Ringer solution (LR)
LR: Lactated Ringer solution. Patients in the LR treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Lactated Ringer Solution
Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Normal saline (NS)
NS: Normal Saline. Patients in the NS treatment arm will receive fluid therapy based on normal saline for a minimum of 48 hours.
Normal saline
Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Interventions
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Lactated Ringer Solution
Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Normal saline
Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
* Chronic pancreatitis defined by a Wirsung duct ≥4mm and/or pancreatic calcifications
* More than 1 previous episode of acute pancreatitis (only 2 episodes of acute pancreatitis are allowed, one of them the present episode)
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Universidad Miguel Hernandez de Elche
OTHER
Hospital del Mar
OTHER
Hospital Clinico Universitario de Santiago
OTHER
Hospital Clínico Universitario de Valencia
OTHER
Hospital Costa del Sol
OTHER
Corporacion Parc Tauli
OTHER
Hospital Clínico Universitario Lozano Blesa
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario La Fe
OTHER
Hospital Miguel Servet
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario Insular Gran Canaria
OTHER
University Hospital Virgen de las Nieves
OTHER
Hospital Universitario de Burgos
OTHER
Hospital Universitario Lucus Augusti
OTHER
Hospital Universitario Marqués de Valdecilla
OTHER
Hospital Universitario Puerta del Mar
OTHER
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
OTHER
Dr. Negrin University Hospital
OTHER
Hospital Regional de Alta Especialidad del Bajio
OTHER
Asian Institute Of Medical Sciences
OTHER
Hospital Dr. Jaime Mendoza Sucre Bolivia
UNKNOWN
Hayatabad Medical Complex
OTHER_GOV
University Hospital Olomouc
OTHER
SIDS Hospital & Research Centre Gujarat India
UNKNOWN
Sanatorio Allende
OTHER
University Hospital Bratislava
OTHER
University Hospital Sestre Milosrdnice
OTHER
Attikon Hospital
OTHER
Nuevo Hospital Iturraspe Santa Fe Argentina
UNKNOWN
Hospital Nacional Rosales
OTHER
Zagazig University
OTHER_GOV
University of Utah
OTHER
Hospitales Universitarios Virgen del Rocío
OTHER
University Hospital of Girona Dr. Josep Trueta
NETWORK
Hospital of Navarra
OTHER
Hospital Clínico Universitario de Valladolid
OTHER
Hospital Universitario Central de Asturias
OTHER
Kalinga Hospital, Bhubaneswar
OTHER
Ohio State University
OTHER
Zhengzhou University
OTHER
Jinling Hospital, China
OTHER
Hospital Privado de Cordoba, Argentina
OTHER
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Postgraduate Institute of Medical Education and Research in Chandigarh
OTHER
RML Specialty Hospital
OTHER
Wannan Medical College Yijishan Hospital
OTHER
Bucharest Emergency Hospital
OTHER
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Emergency County Hospital Pius Brinzeu; Timisoara, Romania
NETWORK
King Hamad University Hospital, Bahrain
OTHER
Enrique de-Madaria
OTHER
Responsible Party
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Enrique de-Madaria
Principal Investigator of clinical pancreatology research group-ERICA consortium, ISABIAL
Principal Investigators
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Enrique de-Madaria, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dr. Balmis General University Hospital
Locations
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Dr. Balmis General University Hospital
Alicante, , Spain
Countries
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References
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Banks PA, Bollen TL, Dervenis C, Gooszen HG, Johnson CD, Sarr MG, Tsiotos GG, Vege SS; Acute Pancreatitis Classification Working Group. Classification of acute pancreatitis--2012: revision of the Atlanta classification and definitions by international consensus. Gut. 2013 Jan;62(1):102-11. doi: 10.1136/gutjnl-2012-302779. Epub 2012 Oct 25.
de-Madaria E, Buxbaum JL, Maisonneuve P, Garcia Garcia de Paredes A, Zapater P, Guilabert L, Vaillo-Rocamora A, Rodriguez-Gandia MA, Donate-Ortega J, Lozada-Hernandez EE, Collazo Moreno AJR, Lira-Aguilar A, Llovet LP, Mehta R, Tandel R, Navarro P, Sanchez-Pardo AM, Sanchez-Marin C, Cobreros M, Fernandez-Cabrera I, Casals-Seoane F, Casas Deza D, Lauret-Brana E, Marti-Marques E, Camacho-Montano LM, Ubieto V, Ganuza M, Bolado F; ERICA Consortium. Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis. N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3.
Guilabert L, Cardenas-Jaen K, Vaillo-Rocamora A, Garcia Garcia de Paredes A, Chhoda A, Sheth SG, Lopez-Valero C, Zapater P, Navarrete-Munoz EM, Maisonneuve P, Hernandez-Barco YG, Capurso G, Buxbaum JL, de-Madaria E; ERICA consortium. Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol. Trials. 2024 Oct 21;25(1):699. doi: 10.1186/s13063-024-08539-2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Published study protocol and statistical analysis plan
Other Identifiers
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Eudract 2023-000010-18
Identifier Type: -
Identifier Source: org_study_id
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