Moderate Versus Aggressive Fluids for Acute Pancreatitis
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|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|
|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.
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
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James L Buxbaum, MD||University of Southern California|