Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol
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 contro...
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2024-10-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08539-2 |
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| author | 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 Yasmin G. Hernández-Barco Gabriele Capurso James L. Buxbaum Enrique de-Madaria for the ERICA consortium |
| author_facet | 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 Yasmin G. Hernández-Barco Gabriele Capurso James L. Buxbaum Enrique de-Madaria for the ERICA consortium |
| author_sort | Lucía Guilabert |
| collection | DOAJ |
| description | 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. |
| format | Article |
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| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | BMC |
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| spelling | doaj-art-d5c70a2a3d7043719c2e793df03378ab2024-11-17T12:47:20ZengBMCTrials1745-62152024-10-0125111610.1186/s13063-024-08539-2Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocolLucía Guilabert0Karina Cárdenas-Jaén1Alicia Vaillo-Rocamora2Ana García García de Paredes3Ankit Chhoda4Sunil G. Sheth5Carlos López-Valero6Pedro Zapater7Eva M. Navarrete-Muñoz8Patrick Maisonneuve9Yasmin G. Hernández-Barco10Gabriele Capurso11James L. Buxbaum12Enrique de-Madaria13for the ERICA consortium14Gastroenterology Department, Balmis General University Hospital, ISABIALGastroenterology Department, Balmis General University Hospital, ISABIALGastroenterology Department, Balmis General University Hospital, ISABIALDepartment of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de AlcaláDivision of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical SchoolDivision of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical SchoolGastroenterology Department, Balmis General University Hospital, ISABIALCentro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)Grupo de Investigación en Terapia Ocupacional (InTeO), Department of Surgery and Pathology, Miguel Hernandez University-ISABIALDivision of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCSDivision of Gastroenterology, Massachusetts General Hospital, Harvard Medical SchoolPancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita-Salute San Raffaele UniversityDivision of Gastroenterology, University of Southern CaliforniaGastroenterology Department, Balmis General University Hospital, ISABIALERICA: International League Against Biliary-Pancreatic DiseasesAbstract 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.https://doi.org/10.1186/s13063-024-08539-2Acute pancreatitisFluid resuscitationLactated Ringer solutionNormal salineRandomized controlled trial |
| spellingShingle | 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 Yasmin G. Hernández-Barco Gabriele Capurso James L. Buxbaum Enrique de-Madaria for the 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 Acute pancreatitis Fluid resuscitation Lactated Ringer solution Normal saline Randomized controlled trial |
| title | Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol |
| title_full | Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol |
| title_fullStr | Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol |
| title_full_unstemmed | Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol |
| title_short | Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol |
| title_sort | normal saline versus lactated ringer s solution for acute pancreatitis resuscitation an open label multicenter randomized controlled trial the waterland trial study protocol |
| topic | Acute pancreatitis Fluid resuscitation Lactated Ringer solution Normal saline Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-024-08539-2 |
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