Moderate Versus Aggressive Fluids for Acute Pancreatitis
|ClinicalTrials.gov Identifier: NCT01761539|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : August 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatitis||Other: Aggressive Hydration Other: Moderate Hydration||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Moderate Versus Aggressive Fluid Therapy in Patient With Mild to Moderate Acute Pancratitis|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
- Clinical Improvement [ Time Frame: 36 hours ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761539
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California|