Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Recruiting

• Conditions: Acute Pancreatitis

• Registration Number: NCT06223594
• Lead Sponsor: Methodist Health System

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-07-17
• Study First Submitted: 2023-11-13
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Last Update Submitted: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25
• Primary Completion: 2024-07-17
• Study Completion: 2024-07-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• ● Age > 18 years

  • Diagnosis of AP based on International Statistical Classification of Diseases( ICD)-10 code

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of fluid overload	72 hours	Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.

Secondary Outcome Measures

Name	Time	Method
number of Effective outcomes	48 hours	decrease in number days of hospital stay

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States