NCT06223594

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2025

Completed
Last Updated

July 25, 2025

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

November 13, 2023

Last Update Submit

July 23, 2025

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Rate of fluid overload

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

    72 hours

Secondary Outcomes (1)

  • number of Effective outcomes

    48 hours

Interventions

Intravenous Fluid TherapyOTHER

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Jessica Crotty, PharmD

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

January 25, 2024

Study Start

July 17, 2023

Primary Completion

July 22, 2025

Study Completion

July 22, 2025

Last Updated

July 25, 2025

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
2 years

Locations

US(1)