Normal saline versus lactated Ringer’s solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial.

Design

International, open-label, parallel-group, randomized, controlled, superiority, multicenter clinical trial.

Setting

International

Status

Active, recruiting centers, pending patient recruitment.

Abstract

Some evidence suggests that fluid resuscitation based on lactated Ringer’s solution (LR) may have an anti-inflammatory effect on acute pancreatitis compared to normal saline (NS) and may be associated with a decrease in severity, but randomized controlled trials showed conflicting results. The aim of WATERLAND is to investigate the efficacy and safety of LR-based fluid therapy compared with NS in patients with acute pancreatitis. The study hypothesis is that moderate resuscitation with LR has an anti-inflammatory effect that is associated with improved outcomes.

Patients will be randomized in a 1:1 ratio to receive either LR or NS-based fluid therapy. The WATERLAND trial is a low-intervention pharmacological clinical trial. Primary outcome variable: development of moderately severe to severe acute pancreatitis according to the revised Atlanta classification. Primary safety variables: composite variable, any of the following complications: fluid overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis.

Ongoing studies