Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

NCT ID: NCT06223594

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2025-07-22

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.

Conditions

Acute Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Intravenous Fluid Therapy

Evaluate the safety and efficacy of the Dallas acute pancreatitis protocol(DAPP) order set on Acute pancreatitis(AP) patients receiving aggressive, goal-directed Intravenous fluid(IVF )therapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jessica Crotty, PharmD

Role: PRINCIPAL_INVESTIGATOR

Methodist Midlothian Medical Center

Locations

Methodist Dallas Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

028.PHA.2023.D

Identifier Type: -

Identifier Source: org_study_id