Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation
Status:
Not yet recruiting
Trial end date:
2026-04-01
Target enrollment:
Participant gender:
Summary
Background: Acute pancreatitis (AP) is an acute inflammatory disease of variable severity.
Mild cases have an uncomplicated clinical course, but local and systemic complications occur
in one-third of patients and are associated with a longer hospital stay, increased morbidity,
increased hospital costs, and increased risk of death. Some evidence suggests that fluid
resuscitation with lactated Ringer's solution (LR) may have an anti-inflammatory effect on AP
when compared to normal saline (NS), and may be associated with a decrease in severity, but
randomized controlled trials showed conflicting results. The WATERLAND trial has been
designed to investigate the efficacy and safety of fluid resuscitation using LR as compared
with 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 moderate fluid resuscitation. The primary outcome will be
moderately severe to severe AP, according to the revision of the Atlanta classification. The
primary safety outcome will be a composite variable involving any of the following: fluid
overload, acute kidney injury, hyperkalemia, hypercalcemia, or acidosis. 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 to severe AP in LR group will be 17%. The frequency in the NS group is assumed to be
27% under the null hypothesis and 17% under the alternative hypothesis. The test statistic
used is the two-sided Z test with pooled variance set at a 0.05 significance level.
Phase:
Phase 4
Details
Lead Sponsor:
Enrique de-Madaria
Collaborators:
Corporacion Parc Tauli Dr. Negrin University Hospital Hospital Clinico Universitario de Santiago Hospital Clínico Universitario de Valencia Hospital Clínico Universitario Lozano Blesa Hospital Costa del Sol Hospital del Mar Hospital General Universitario Gregorio Marañon Hospital Miguel Servet Hospital Universitario de Burgos Hospital Universitario Insular Gran Canaria Hospital Universitario La Fe Hospital Universitario Lucus Augusti Hospital Universitario Marqués de Valdecilla Hospital Universitario Puerta del Mar Hospital Universitario Ramon y Cajal Instituto de Investigación Sanitaria Hospital Universitario de la Princesa Instituto de Salud Carlos III Universidad Miguel Hernandez de Elche University Hospital Virgen de las Nieves