生理盐水与乳酸林格氏液用于急性胰腺炎复苏的比较：一项开放标签、多中心随机对照试验：WATERLAND 试验研究方案。
Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.
机构信息
Gastroenterology Department, Balmis General University Hospital, ISABIAL, Alicante, Dr, Spain.
Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá, Madrid, Spain.
出版信息
Trials. 2024 Oct 21;25(1):699. doi: 10.1186/s13063-024-08539-2.
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.
背景
一些证据表明，与生理盐水（NS）相比，乳酸林格氏液（LR）的液体复苏可能对急性胰腺炎（AP）具有抗炎作用，并且可能与严重程度降低相关，但现有的单中心随机对照试验结果存在矛盾。WATERLAND 试验旨在研究与 NS 相比，LR 在 AP 患者中的液体复苏的疗效和安全性。
方法
WATERLAND 试验是一项国际性多中心、开放标签、平行组、随机、对照、优效性试验。患者将按 1:1 比例随机分配接受 LR 或 NS 为基础的液体复苏，至少 48 小时。主要结局将根据亚特兰大分类的修订标准评估为中度或重度 AP。WATERLAND 试验的次要目标是确定 LR 与 NS 液体复苏对 AP 患者的几项疗效和安全性结局的影响。预计将有 720 名患者，LR 组 360 名，NS 组 360 名，每组 90%的效能检测组间比例 10%的差异，假设 LR 组中度或重度 AP 的频率为 17%。预计会有 10%的患者失访，因此每组的总样本量将为 396 名患者（总共 792 名患者）。使用双侧 Z 检验，采用合并方差，检验水准为 0.05。
讨论
WATERLAND 研究旨在改善 AP 的早期管理。液体复苏是一种在世界上任何医院都可获得的廉价治疗方法。如果在治疗组之一中显示出胰腺炎的更好演变，这将对这种常见疾病的管理产生重要影响。
试验注册
ClinicalTrials.gov，NCT05781243。注册日期为 2023 年 1 月 4 日。EudraCT 编号 2023-000010-18，首次发布于 2023 年 3 月 23 日。
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