Clinical trial NCT06223594: Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol
Official title: Evaluation of Intravenous Fluid Therapy Within Dallas Acute Pancreatitis Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pancreatitis
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Age \> 18 years
* Diagnosis of AP based on ICD-10 code

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.

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

Primary outcomes:
measure: Rate of fluid overload
timeFrame: 72 hours
Secondary outcomes:
measure: number of Effective outcomes
timeFrame: 48 hours
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Midlothian Medical Center
name: Jessica Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References: