Clinical Trial: Moderate Versus Aggressive Fluids for Acute Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Moderate Versus Aggressive Fluid Therapy in Patient With Mild to Moderate Acute Pancratitis

Brief Summary: 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.

Detailed Summary:

TITLE: Moderate Versus Aggressive Fluid Therapy in Patients with Mild to Moderate Acute Pancreatitis

BACKGROUND AND HYPOTHESES In the United States, acute pancreatitis results in more than 200,000 hospital admissions each year and has an associated mortality of 5%. While protease inhibitors, platelet activating factor inhibitors, and somatostatin have been studied, no pharmacologic agents have been shown to impact the course of acute pancreatitis and the treatment remains supportive. Fluid resuscitation has been recommended based on animal data, however, until recently very limited clinical studies were available to assess its impact. Animal studies using rats, dogs, and pigs suggest that acute pancreatitis compromises splanchnic perfusion and the pancreatic microcirculation. Work by Banks et al demonstrated that hemoconcentration is associated with necrosis and inadequate resuscitation in those with elevated hematocrit was associated with markedly increased rates of necrosis. Blood urea nitrogen and creatinine levels also appear to correlate with mortality in acute pancreatitis.

Nonetheless, recent studies have yielded contradictory results regarding whether fluids should be used judiciously or liberally. Retrospective work by Gardner suggests that early resuscitation is beneficial. Other recent studies however including the work by De Madaria et al suggest that those were received more than 4.1L of fluids during the first 24 hours were more likely to develop organ failure than those who received less. In the only randomized controlled trial of fluids in acute pancreatitis 76 patients with severe pancreatitis, including those with renal failure, were randomized to massive 10-15cc/kg/hr (mean of 545 cc/hour) versus less aggressive resuscitation, 5-10cc/kg/hr. Rates of mechanical ventilation, abdominal compartment syndrome,
Sponsor: University of Southern California

Current Primary Outcome: Clinical Improvement [ Time Frame: 36 hours ]

Decreased hematocrit, BUN, Cr compared to time zero, decreased epigastric pain, and ability to tolerate PO's.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of Southern California

Dates:
Date Received: January 3, 2013
Date Started: April 2013
Date Completion:
Last Updated: July 31, 2016
Last Verified: July 2016