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
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The WATERLAND trial aims to investigate the efficacy and safety of fluid resuscitation using LR compared to NS in patients with AP.</p><p><strong>Methods: </strong>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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. 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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.</p><p><strong>Discussion: </strong>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.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05781243. Registration date on January 4, 2023. 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引用次数: 0
摘要
背景：一些证据表明，与普通生理盐水（NS）相比，使用乳酸林格氏液（LR）进行液体复苏可能对急性胰腺炎（AP）具有抗炎作用，并可能降低严重程度，但现有的单中心随机对照试验显示出相互矛盾的结果。WATERLAND试验旨在研究在急性胰腺炎患者中使用LR与NS进行液体复苏的有效性和安全性：WATERLAND 试验是一项国际多中心、开放标签、平行组、随机对照、优效性试验。患者将按 1:1 的比例随机分配接受 LR 与 NS 液体复苏至少 48 小时。主要结果是根据亚特兰大分类修订版确定的中度或重度 AP。WATERLAND 试验的次要目标是确定 LR 与 NS 液体复苏对 AP 患者疗效和安全性的影响。假设 LR 组患者中度或重度 AP 的发生率为 17%，则总样本数为 720 例患者（LR 组 360 例，NS 组 360 例），将有 90% 的力量检测到两组比例相差 10%。预计将有 10%的患者失去随访，因此每个治疗组的总样本量将为 396 名患者（总计 792 名患者）。使用的检验统计量是双侧 Z 检验，集合方差的显著性水平设定为 0.05：WATERLAND 研究旨在改善 AP 的早期管理。液体复苏是一种廉价的治疗方法，在全球任何医院中心都可使用。如果其中一种治疗方法能改善胰腺炎的发展，将对这种常见疾病的治疗产生重要影响：试验注册：ClinicalTrials.gov，NCT05781243。注册日期为 2023 年 1 月 4 日。EudraCT编号2023-000010-18，2023年3月23日首次发布。
Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.
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.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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