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Normal Saline for Acute Pancreatitis

N/A
Waitlist Available
Led By James Buxbaum, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Presentation with acute pancreatitis as defined by two of three criterion; amylase or lipase \> 3x the upper limit of normal, classical abdominal pain, or imaging suggestive of pancreatitis. Such radiographic findings include swelling, edema, or heterogeneity of the gland or peripancreatic fluid or stranding.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

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.

Eligible Conditions
  • Acute Pancreatitis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
SIRS at 24 hours
Secondary outcome measures
Advance diet
ICU admission
Length of hospitalization
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Normal SalineExperimental Treatment1 Intervention
Patients will receive fluid administration of Normal Saline solution at a pre-determined volume algorithm that is the same for both arms
Group II: Lactated RingerActive Control1 Intervention
Patients will receive fluid administration of Lactated Ringer's solution at a pre-determined volume algorithm that is the same for both arms

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
936 Previous Clinical Trials
1,613,360 Total Patients Enrolled
3 Trials studying Acute Pancreatitis
1,798 Patients Enrolled for Acute Pancreatitis
James Buxbaum, MDPrincipal InvestigatorUniversity of Southern California
6 Previous Clinical Trials
989 Total Patients Enrolled
~17 spots leftby Sep 2025