Abstract

Background

Some 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.

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 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 registration

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

Details

Title
Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol
Author
Guilabert, Lucía 1 ; Cárdenas-Jaén, Karina 1 ; Vaillo-Rocamora, Alicia 1 ; García García de Paredes, Ana 2 ; Chhoda, Ankit 3 ; Sheth, Sunil G. 3 ; López-Valero, Carlos 1 ; Zapater, Pedro 4 ; Navarrete-Muñoz, Eva M. 5 ; Maisonneuve, Patrick 6 ; Hernández-Barco, Yasmin G. 7 ; Capurso, Gabriele 8 ; Buxbaum, James L. 9 ; de-Madaria, Enrique 10   VIAFID ORCID Logo 

1  Balmis General University Hospital, ISABIAL, Gastroenterology Department, Alicante, Spain (GRID:grid.513062.3) (ISNI:0000 0004 8516 8274) 
2  Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá, Department of Gastroenterology and Hepatology, Madrid, Spain (GRID:grid.411347.4) (ISNI:0000 0000 9248 5770); Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain (GRID:grid.452371.6) (ISNI:0000 0004 5930 4607) 
3  Beth Israel Deaconess Medical Center, Harvard Medical School, Division of Gastroenterology, Boston, USA (GRID:grid.38142.3c) (ISNI:000000041936754X) 
4  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain (GRID:grid.452371.6) (ISNI:0000 0004 5930 4607); Dr. Balmis General University Hospital, ISABIAL, Clinical Pharmacology Department, Alicante, Spain (GRID:grid.513062.3) (ISNI:0000 0004 8516 8274); IDiBE, Miguel Hernandez University, Elche, Spain (GRID:grid.26811.3c) (ISNI:0000 0001 0586 4893) 
5  Miguel Hernandez University-ISABIAL, Grupo de Investigación en Terapia Ocupacional (InTeO), Department of Surgery and Pathology, Alicante, Spain (GRID:grid.26811.3c) (ISNI:0000 0001 0586 4893); Joint Research Unit UMH-Fisabio (STATSALUT), Alicante, Spain (GRID:grid.26811.3c) 
6  IEO European Institute of Oncology IRCCS, Division of Epidemiology and Biostatistics, Milan, Italy (GRID:grid.15667.33) (ISNI:0000 0004 1757 0843) 
7  Massachusetts General Hospital, Harvard Medical School, Division of Gastroenterology, Boston, USA (GRID:grid.38142.3c) (ISNI:000000041936754X) 
8  Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita-Salute San Raffaele University, Pancreato-Biliary Endoscopy and Endosonography Division, Milan, Italy (GRID:grid.15496.3f) (ISNI:0000 0001 0439 0892) 
9  University of Southern California, Division of Gastroenterology, Los Angeles, USA (GRID:grid.42505.36) (ISNI:0000 0001 2156 6853) 
10  Balmis General University Hospital, ISABIAL, Gastroenterology Department, Alicante, Spain (GRID:grid.513062.3) (ISNI:0000 0004 8516 8274); Miguel Hernandez University, Department of Clinical Medicine, Elche, Spain (GRID:grid.26811.3c) (ISNI:0000 0001 0586 4893) 
Pages
699
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08539-2
ProQuest document ID
3118967203
Copyright
© The Author(s) 2024. corrected publication 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.