Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Acute Pancreatitis Clinical Trial

Official title:

Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223594
• Other study ID #: 028.PHA.2023.D
• Status: Recruiting
• Start date: July 17, 2023
• Est. completion date: July 17, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Bethany Brauer, MPH
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 17, 2024
• Est. primary completion date: July 17, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of fluid overload	Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.	72 hours
Secondary	number of Effective outcomes	decrease in number days of hospital stay	48 hours