Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Last updated: January 16, 2024
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pancreatitis

Treatment

Intravenous Fluid Therapy

Clinical Study ID

NCT06223594
028.PHA.2023.D
  • Ages 18-75
  • All Genders

Study Summary

Acute pancreatitis (AP) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ● Age > 18 years
  • Diagnosis of AP based on International Statistical Classification of Diseases(ICD)-10 code

Exclusion

Exclusion Criteria:

  • ● Diagnosis of chronic pancreatitis
  • Patients who did not follow the IVF infusion protocol
  • Received < 24 hours of IVF therapy
  • Transferred from another institution

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Intravenous Fluid Therapy
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
July 17, 2024

Study Description

In the last 20 years, the incidence of AP and rate of hospitalization have steadily increased. Approximately, two-thirds of AP patients will have a mild and self-limiting course of the disease, leaving the remaining one-third experiencing moderately severe to severe disease that is associated with worse outcomes. Overall, the estimated mortality of pancreatitis is 1% however, mortality can be as high as 30% to 40% among patients with AP and organ failure or pancreatic necrosis. Despite numerous randomized clinical trials, there is no medication shown to be successful at treating AP.

AP is associated with fluid deficit secondary to low intake and vomiting. Early intravenous fluid (IVF) resuscitation has been long-established as the initial cornerstone treatment to prevent hypovolemia and subsequent organ failure within the first 48 to 72 hours. The rationale for such intervention is to provide adequate intravascular volume support to counteract fluid shift into the third space. However, available evidence for an effective fluid regimen is lacking with regard to the type of fluid, the optimal rate of administration, and how to assess appropriate goals/targets for adequate resuscitation. Furthermore, the literature has presented conflicting results on whether aggressive versus goal-directed fluid resuscitation will lead to a reduction in mortality and improve outcomes. Although early supportive care with IVF therapy is recommended by the major guidelines, there are potential, serious complications associated with aggressive resuscitation, including volume overload, respiratory failures, intra-abdominal compartments.

Connect with a study center

  • Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Active - Recruiting

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