Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol

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

Study Overview

• Status: Recruiting
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Other: Intravenous Fluid Therapy

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Colette Ngo Ndjom, MS; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
• Study Contact Backup: Name: Bethany Brauer, MPH; Phone Number: 214-947-4681; Email: mhsirb@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Bethany Brauer, MPH; Phone Number: 217-947-4681; Email: mhsirb@mhd.com
      • Contact: Bethany Ngo Ndjom, MS; Phone Number: 71281 214-947-4681; Email: mhsirb@mhd.com
      • Principal Investigator: Jessica Crotty, PharmD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

• Age > 18 years
• Diagnosis of AP based on ICD-10 code

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of fluid overload	Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of Effective outcomes	decrease in number days of hospital stay	48 hours

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Jessica Crotty, PharmD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): July 17, 2024
• Study Completion (Estimated): July 17, 2024

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 028.PHA.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The PI is committed to disseminate research results in a timely fashion. Sharing of data generated by this project will be carried out through presentation at scientific meetings and/or publication in Open Access Journals
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No