We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Moderate Versus Aggressive Fluids for Acute Pancreatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01761539
First Posted: January 4, 2013
Last Update Posted: August 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
James Buxbaum, University of Southern California
  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
Intervention Model: Crossover Assignment
Masking: None (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 James Buxbaum, University of Southern California:

Primary Outcome Measures:
  • Clinical Improvement [ Time Frame: 36 hours ]
    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 ]
    Time required to reach clinical improvement (as defined in primary outcome measure)

  • Requirement for aggressive hydration [ Time Frame: 36 hours ]
    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 ]
    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 ]
    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 ]
    Physical exam findings of pitting edema, ascites, anasacra, pulmonary edema, or dyspnea.


Enrollment: 60
Study Start Date: April 2013
Study Completion Date: November 2015
Primary Completion Date: November 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mild to moderate pancreatitis

Exclusion Criteria:

  • SIRS (2/4) a) HR >90 b) RR>20 or paCO2 <32 on room air c) T>100.4 F <96.8 F d) WBC >12, <4 or >10%
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761539


Locations
United States, California
Los Angeles County Hospital
Los Angeles, California, United States, 90033
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
First Submitted: January 3, 2013
First Posted: January 4, 2013
Last Update Posted: August 2, 2016
Last Verified: July 2016

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

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases