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

Summary

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.

Conditions

• Acute Pancreatitis

Interventions

DRUG

Lactated Ringer Solution

Patients in the LR (Lactated Ringer solution) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.

DRUG

Normal saline

Patients in the NS (Normal Saline) treatment arm will receive fluid therapy based on lactated Ringer's solution for a minimum of 48 hours.

Sponsors & Collaborators

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Universidad Miguel Hernandez de Elche

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Hospital Clinico Universitario de Santiago

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Hospital Costa del Sol

  collaborator OTHER

• Corporacion Parc Tauli

  collaborator OTHER

• Hospital Clínico Universitario Lozano Blesa

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Miguel Servet

  collaborator OTHER

• Hospital Universitario Ramon y Cajal

  collaborator OTHER

• Hospital Universitario Insular Gran Canaria

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Hospital Universitario de Burgos

  collaborator OTHER

• Hospital Universitario Lucus Augusti

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Universitario Puerta del Mar

  collaborator OTHER

• Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

  collaborator OTHER

• Dr. Negrin University Hospital

  collaborator OTHER

• Hospital Regional de Alta Especialidad del Bajio

  collaborator OTHER

• Asian Institute Of Medical Sciences

  collaborator OTHER

• Hospital Dr. Jaime Mendoza Sucre Bolivia

  collaborator UNKNOWN

• Hayatabad Medical Complex

  collaborator OTHER_GOV

• University Hospital Olomouc

  collaborator OTHER

• SIDS Hospital & Research Centre Gujarat India

  collaborator UNKNOWN

• Sanatorio Allende

  collaborator OTHER

• University Hospital Bratislava

  collaborator OTHER

• University Hospital Sestre Milosrdnice

  collaborator OTHER

• Attikon Hospital

  collaborator OTHER

• Nuevo Hospital Iturraspe Santa Fe Argentina

  collaborator UNKNOWN

• Hospital Nacional Rosales

  collaborator OTHER

• Zagazig University

  collaborator OTHER_GOV

• University of Utah

  collaborator OTHER

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• University Hospital of Girona Dr. Josep Trueta

  collaborator NETWORK

• Hospital of Navarra

  collaborator OTHER

• Hospital Clínico Universitario de Valladolid

  collaborator OTHER

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Kalinga Hospital, Bhubaneswar

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Zhengzhou University

  collaborator OTHER

• Jinling Hospital, China

  collaborator OTHER

• Hospital Privado de Cordoba, Argentina

  collaborator OTHER

• Prince of Wales Hospital, Shatin, Hong Kong

  collaborator OTHER

• Postgraduate Institute of Medical Education and Research in Chandigarh

  collaborator OTHER

• RML Specialty Hospital

  collaborator OTHER

• Wannan Medical College Yijishan Hospital

  collaborator OTHER

• Bucharest Emergency Hospital

  collaborator OTHER

• The First Affiliated Hospital of Henan University of Science and Technology

  collaborator OTHER

• Emergency County Hospital Pius Brinzeu; Timisoara, Romania

  collaborator NETWORK

• King Hamad University Hospital, Bahrain

  collaborator OTHER

• Enrique de-Madaria

  lead OTHER

Principal Investigators

• Enrique de-Madaria, MD PhD · Dr. Balmis General University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-19

Primary Completion

2024-09-30

Completion

2024-09-30

Countries

• Spain

Study Locations