Moderate Versus Aggressive Fluids for Acute Pancreatitis
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.
|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|
- 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.
- 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.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761539
|Contact: James Buxbaum, MD||323 409 firstname.lastname@example.org|
|Contact: Maria Trujillo||323 409 email@example.com|
|United States, California|
|Los Angeles County Hospital||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Maria Trujillo, MD 323-409-5371 firstname.lastname@example.org|
|Principal Investigator: James Buxbaum, MD|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California|