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Lactated Ringer's Versus Normal Saline for Acute Pancreatitis

NCT03642769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2021-12-08

No results posted yet for this study

Summary

Acute pancreatitis is a common problem in the United States necessitating 275,000 hospital admissions per year, with resultant healthcare costs of approximately 2.5 billion USD annually. As numerous trials have failed to show a benefit to specific pharmacologic therapies in acute pancreatitis, the mainstay of treatment has been both supportive care and early, aggressive fluid resuscitation. Small randomized studies have shown conflicting results with regards to the influence of resuscitation fluid on outcomes in acute pancreatitis, necessitating a large randomized trial to clarify if fluid choice matters or not in the treatment of acute pancreatitis.

The objective of this study is to assess the comparative efficacy of normal saline versus lactated ringer's solution in the management of acute pancreatitis.

Patients presenting to the Los Angeles County Hospital with acute pancreatitis will be randomized to fluid resuscitation with NS or LR with volumes of fluid administered according to a pre-determined algorithm that will be the same for both treatment arms.

The primary outcome of the study will be the change in SIRS prevalence from enrollment to 24 hours. Secondary outcomes will include the change in SIRS prevalence from enrollment to 48 hours and 72 hours, development of moderately severe or severe pancreatitis, change in PASS score, ICU admission, length of hospitalization, persistent pain or disability after discharge, and time of advancement to oral diet and discharge.

Conditions

  • Pancreatitis, Acute

Interventions

OTHER

Fluid administration

Fluid administration of bolus and maintenance fluids

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • James Buxbaum, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2021-08-16
Completion
2021-08-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03642769 on ClinicalTrials.gov