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NCT03642769

Lactated Ringer's Versus Normal Saline for Acute Pancreatitis

Completed NA Last updated 8 December 2021
What this trial tests

NA trial testing Fluid administration in Pancreatitis, Acute in 121 participants. Completed in 16 August 2021.

Timeline
18 September 2018
Primary endpoint
16 August 2021
16 August 2021

Quick facts

Lead sponsorUniversity of Southern California
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment121
Start date18 September 2018
Primary completion16 August 2021
Estimated completion16 August 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Southern California

Who can join

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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evidence-Based Approach to the Surgical Management of Acute Pancreatitis.
    Sagar AJ, Khan M, Tapuria N. · · 2022 · cited 3× · PMID 36425407 · DOI 10.1055/s-0042-1758229

Verify or expand the search:

Other trials of Fluid administration

Trials testing the same drug.

Other recruiting trials for Pancreatitis, Acute

Currently open trials in the same condition.

Other University of Southern California trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing