Acute PancreatitisNCT06223594
Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol
An observational study of Acute Pancreatitis, run by Methodist Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Intravenous Fluid Therapy
- Type of treatment
- Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 22 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: * Age > 18 years * Diagnosis of AP based on ICD-10 code
Who may be able to join
- ● Age > 18 years
- Diagnosis of AP based on International Statistical Classification of Diseases( ICD)-10 code
Who cannot join
- ● Diagnosis of chronic pancreatitis
- Patients who did not follow the IVF infusion protocol
- Received < 24 hours of IVF therapy
- Transferred from another institution
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Acute pancreatitis (AP) is a common disease of the gastrointestinal tract that can result in emotional, physical, and financial burdens on the patient.
Read the 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
- Being tested
- Intravenous Fluid Therapy
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fluid overload
Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.
Measured: 72 hours
Secondary outcomes (1)
number of Effective outcomes
decrease in number days of hospital stay
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start17 Jul 2023
- Primary completion22 Jul 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Crotty, PharmD, Principal investigator, Methodist Midlothian Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223594
- Sponsor's protocol ID
- 028.PHA.2023.D
- Status last verified
- Jul 2024
- First submitted
- 13 Nov 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol
- ClinicalTrials.gov ID
- NCT06223594
- Acronym / sponsor ID
- 028.PHA.2023.D
- Conditions
- Acute Pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 22 Jul 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * Age > 18 years * Diagnosis of AP based on ICD-10 code
Key inclusion criteria (2 listed)
- ● Age > 18 years
Key exclusion criteria (4 listed)
- ● Diagnosis of chronic pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Fluid TherapyEvaluate 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. | Other | – |
Primary outcome
Rate of fluid overload
Time frame: 72 hours
Rate of fluid overload at 72 hours, which is the absence of acute respiratory distress syndrome.
1 secondary outcome
number of Effective outcomes
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Crotty, PharmD principal investigator
Methodist Midlothian Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pancreatitis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fluid overload (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.