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Phosphate in Acute Pancreatitis (PPP)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this study is to learn if phosphate administration works to treat acute pancreatitis in adults presenting to the emergency department at Duke University Hospital. The main questions it aims to answer are: * Does having low phosphate levels increase the risk of acute pancreatitis and can giving phosphate through an IV make the illness less severe? * Is phosphate therapy practical to use, and what is the appropriate dose? * Is this study achievable, and how can the results help design a future randomized controlled trial to assess safety and effectiveness? Participants will: * Receive standard of care or intravenous (IV) phosphate during their hospital stay * Have blood samples collected during admission to monitor phosphorus levels * Complete follow-up assessments after hospital admission to evaluate how severe the illness is and the effects of phosphate supplementation

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Presenting to the emergency department (ED) with acute pancreatitis meeting 2 or more characteristics of: (1) typical, persistent, severe upper abdominal pain, (2) lipase or amylase levels at least three times greater than the upper limit of normal, and/or (3) characteristic findings on abdominal imaging)

• Trial treatment can be initiated within 24 hours of hospital admission

• Consent can be obtained from the patient or their legal representative

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Samuel Francis, MD
samuel.francis@duke.edu
919-684-5537
Time Frame
Start Date: 2026-07-09
Estimated Completion Date: 2029-01
Participants
Target number of participants: 100
Treatments
No_intervention: Standard of Care Observational Phase
During the first year of enrollment, 50 control group participants will be enrolled in an observational phase and receive usual care only with fluid resuscitation at the discretion of the clinical team. Serum phosphorus levels will be checked every 6 hours and additional blood samples will be collected daily to monitor patients' lab values during their hospital stay.
Experimental: Phosphate Treatment Phase
During the second year of enrollment, 50 treatment group participants will be enrolled and receive usual care plus continuous sodium phosphate or potassium phosphate (in the case of hypernatremia) which will be delivered by continuous peripheral intravenous infusion at a rate of 30 mmol every 6 hours, as long as serum phosphorus levels are ≤ 4.0 mg/dL. Phosphate infusion will be initiated as soon as possible after patient enrollment and continued for a maximum duration of 72 hours or until patient discharge from the hospital, whichever occurs sooner. Serum phosphorus levels will be checked every 6 hours, and the infusion will be paused until the next recheck if the level rises \>4.0 mg/dL. Additional blood samples will be collected daily to monitor patients' lab values during their hospital stay.
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Duke University

This content was sourced from clinicaltrials.gov