Evidence map›Paper›PMID 39434191›Full record

ArticleTrials2024

Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.

Lucía Guilabert, Karina Cárdenas-Jaén, Alicia Vaillo-Rocamora, Ana García García de Paredes, Ankit Chhoda, Sunil G Sheth, Carlos López-Valero, Pedro Zapater, Eva M Navarrete-Muñoz, Patrick Maisonneuve and 5 more

Erratum issued Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05781243 (Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05781243 phase4completednot on this map

Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation, an Open-label Multicenter Randomized Controlled Trial: the WATERLAND Trial

TypeinterventionalSponsorEnrique de-MadariaRan2023 to 2024Enrolled812ConditionsAcute PancreatitisArmsLactated Ringer Solution, Normal saline
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Acute pancreatitis: mechanisms and therapeutic approaches.Signal transduction and targeted therapy · 2026
    Review
  4. Article
  5. Acute pancreatitis: Translating early mechanisms to bedside management.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025
    Review
  6. Review
  7. Review
  8. [Pancreatitis from drugs-Drugs for treatment of pancreatitis].Innere Medizin (Heidelberg, Germany) · 2025
    Review
  9. Review
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Lucía GuilabertGastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain.
Karina Cárdenas-JaénGastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain.
Alicia Vaillo-RocamoraGastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain.
Ana García García de ParedesDepartment of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá, Madrid, Spain.
Ankit ChhodaDivision of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Sunil G ShethDivision of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Carlos López-ValeroGastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain.
Pedro ZapaterCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.
Eva M Navarrete-MuñozGrupo de Investigación en Terapia Ocupacional (InTeO), Department of Surgery and Pathology, Miguel Hernandez University-ISABIAL, Alicante, Spain.
Patrick MaisonneuveDivision of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, Milan, Italy.
Yasmin G Hernández-BarcoDivision of Gastroenterology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Gabriele CapursoPancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita-Salute San Raffaele University, Milan, Italy.
James L BuxbaumDivision of Gastroenterology, University of Southern California, Los Angeles, CA, USA.
Enrique de-MadariaGastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain. demadaria@ericaresearch.com.ORCID http://orcid.org/0000-0002-2412-9541
ERICA consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSome evidence suggests that fluid resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on acute pancreatitis (AP) when compared to normal saline (NS) and may be associated with a decrease in severity, but existing single-center randomized controlled trials showed conflicting results. The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP.

methodsThe 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 h. 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.

trial registrationClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. EudraCT number 2023-000010-18, first posted March 23, 2023.

Indexed as

Fluid TherapyMulticenter Studies as TopicPancreatitisRinger's LactateSaline SolutionAcute DiseaseAdultEquivalence Trials as TopicFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicResuscitationTime FactorsTreatment OutcomeRinger's LactateSaline SolutionAcute pancreatitisFluid resuscitationLactated Ringer solutionNormal salineRandomized controlled trial

Identifiers

PMID39434191
PMCPMC11492666

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.