NCT05781243: WATERLAND

Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation

Completed Phase 4 Last updated 20 January 2025

What this trial tests

Phase 4 trial testing Lactated Ringer Solution in Acute Pancreatitis in 792 participants. Completed in 30 September 2024.

Timeline

19 June 2023

Primary endpoint
30 September 2024

30 September 2024

Quick facts

Lead sponsor	Enrique de-Madaria
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	792
Start date	19 June 2023
Primary completion	30 September 2024
Estimated completion	30 September 2024
Sites	1 location across Spain

Drugs / interventions tested

• Lactated Ringer Solution
• Normal saline

Conditions studied

• Acute Pancreatitis — all drugs for Acute Pancreatitis →

Sponsor

Enrique de-Madaria

Who can join

18 and older, any sex, with Acute Pancreatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 hours. 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.
   Guilabert L, Cárdenas-Jaén K, Vaillo-Rocamora A, García García de Paredes A, et al · · 2024 · cited 11× · PMID 39434191 · DOI 10.1186/s13063-024-08539-2
2. Fluid Therapy in Acute Pancreatitis-Current Knowledge and Future Perspectives.
   Caban M, Zatorski H, Małecka-Wojciesko E. · · 2025 · cited 1× · PMID 41304848 · DOI 10.3390/ph18111601