Moderate Versus Aggressive Fluids for Acute Pancreatitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Southern California
Sponsor:
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
ClinicalTrials.gov Identifier:
NCT01761539
First received: January 3, 2013
Last updated: June 29, 2014
Last verified: June 2014
  Purpose

Fluid resuscitation for pancreatitis is recommended given evidence that hemoconcentration is associated with necrosis. However, there is insufficient evidence to support whether resuscitation should be moderate or aggressive. In this study the investigators aim to compare the clinical outcome associated with these strategies in a clinical randomized fashion to determine the optimal treatment of acute pancreatitis.


Condition Intervention
Pancreatitis
Other: Aggressive Hydration
Other: Moderate Hydration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Moderate Versus Aggressive Fluid Therapy in Patient With Mild to Moderate Acute Pancratitis

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Clinical Improvement [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Decreased hematocrit, BUN, Cr compared to time zero, decreased epigastric pain, and ability to tolerate PO's.


Secondary Outcome Measures:
  • Time to reach clinical improvement [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Time required to reach clinical improvement (as defined in primary outcome measure)

  • Requirement for aggressive hydration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Patients initally in the moderate hydration arm who have an increase in BUN, CR, Hematocrit, or epigastric pain and thus are crossed over to the aggressive hydration arm.

  • Systemic Inflammatory Response Syndrome (SIRS) [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    SIRS will be defined based on having 2 out of 4 possible criterion. A) heart rate >90, respiratory rate >20, Temperature greater than 100.4 degrees farenheit or less than 96.8 degrees farenheit. White blood count >10 of <4.

  • Severe Pancreatitis [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
    Severe pancreatitis will be defined if 1 of the following is present; pancreatic necrosis (>30%) or abscess, blood pressure <90mmHg, oxygen saturation <90%, Cr >2mg/dl after 12 hours of resuscitation, >10 days hospitalization, or pseudocyst. Pseudocyst is deefined as a peripancreatic fluid collection which does not resorb within 4-8 weeks.

  • Fluid Overload [ Time Frame: 36 hours ] [ Designated as safety issue: Yes ]
    Physical exam findings of pitting edema, ascites, anasacra, pulmonary edema, or dyspnea.


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aggressive Hydration
Receives Lactated Ringers solution at 3cc/kg/hr following an initial 20cc/kg bolus.
Other: Aggressive Hydration
Receives 20cc/kg bolus and 3cc/kg/hr thereafter.
Active Comparator: Moderate Hydration
Receives Lactated Ringers solution at 1.5cc/kg/hr following an initial 10cc/kg bolus.
Other: Moderate Hydration
Receives 10cc/kg bolus and 1.5cc/kg/hr thereafter.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate pancreatitis

Exclusion Criteria:

  • severe pancreatitis
  • renal insufficiency, Cr >2 mg/dl
  • cardiac insufficiency
  • respiratory insufficiency, O2 saturation <90% room air
  • liver dysfunction, aklbumin <3mg/dL
  • pregnancy
  • hyponatremia, Na < 135meq/L
  • clinical findings of volume overload peripheral edema ascites
  • pancreatitis following endoscopic, radiographic, or surgical procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761539

Contacts
Contact: James Buxbaum, MD 323 409 5371 jbuxbaum@usc.edu
Contact: Maria Trujillo 323 409 0939 mit@usc.edu

Locations
United States, California
Los Angeles County Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Maria Trujillo, MD    323-409-5371    mit@usc.edu   
Principal Investigator: James Buxbaum, MD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: James L Buxbaum, MD University of Southern California
  More Information

Publications:

Responsible Party: James Buxbaum, Director of Endoscopy, Los Angeles County Hospital, University of Southern California
ClinicalTrials.gov Identifier: NCT01761539     History of Changes
Other Study ID Numbers: HS-12-00499
Study First Received: January 3, 2013
Last Updated: June 29, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by University of Southern California:
pancreatitis
pancreatitis, alcoholic

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 19, 2014