Phosphate in Acute Pancreatitis (PPP)

Phosphate in Acute Pancreatitis (PPP)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatitis
• Intervention / Treatment: Drug: Sodium Phosphate; Drug: Potassium Phosphate

Detailed Description

This prospective, two-phase pilot clinical trial will enroll 100 adult emergency department patients with acute pancreatitis (50 per phase) at Duke University Hospital.

Phase one will consist of an observational control group receiving usual care, with serum phosphorus collected throughout the emergency department visit and hospitalization to examine how phosphorus levels change over time and relate to disease severity and clinical outcomes.

Phase two will include a treatment group receiving continuous intravenous sodium phosphate or potassium phosphate infusions to maintain high-normal serum phosphorus levels (4.0-4.5 mg/dL) during the first 72 hours of hospitalization. Phosphate dosing requirements will be determined and compared across varying levels of disease severity to assess whether more severe illness is associated with greater supplementation needs.

Overall, the study will characterize phosphorus dynamics in acute pancreatitis, evaluate the feasibility and dosing of phosphate repletion, and generate preliminary data to inform the design of a future randomized controlled trial assessing the safety and efficacy of phosphate therapy.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Samuel Francis, MD; Phone Number: 919-684-5537; Email: samuel.francis@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
      • Contact: Lezly Collins; Email: lezly.collins@duke.edu
      • Principal Investigator: Samuel Francis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

Contraindications to injectable phosphate including:

• Hyperkalemia
• Hypercalcemia or significant hypocalcemia
• Severe renal impairment (eGFR <30 mL/min/1.73m2) or end-stage renal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Sodium Phosphate; The treatment is administered via continuous peripheral intravenous infusion at a rate of 30 mmol every 6 hours, provided serum phosphorus levels remain at or below 4.0 mg/dL; it begins upon patient enrollment and continues for up to 72 hours.; Other Names: Sodium Phosphate Injection, USP, 3mM P/mL; Drug: Potassium Phosphate; This treatment will be used in case of hypernatremia. The treatment is administered via continuous peripheral intravenous infusion at a rate of 30 mmol every 6 hours, provided serum phosphorus levels remain at or below 4.0 mg/dL; it begins upon patient enrollment and continues for up to 72 hours.; Other Names: Potassium Phosphates Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Phosphorus Levels	Serum phosphorus levels measured in a control (observational) group of patients with acute pancreatitis. This will be determined utilizing the Revised Atlanta Classification.	During hospitalization, up to approximately 7 days
Disease Severity as measured by the Revised Atlanta Classification (RAC)	The RAC is categorized into three levels based on the absence or presence of organ failure and local or systemic complications: Mild = No organ failure and no local or systemic complications, Moderately Severe = Transient organ failure (resolving within 48 hours) OR local/systemic complications without persistent organ failure, Severe = Persistent organ failure (lasting more than 48 hours) that can involve a single or multiple organ systems.	During hospitalization, up to approximately 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosing Requirements	Determine the dosing requirements of phosphate treatment in a treatment group of patients with acute pancreatitis to maintain a high-normal phosphorus level (4.0-4.5 mg/dL) during their emergency department (ED) and hospital stay, with serum phosphorus levels being measured every 6 hours.	During the first 72 hours of hospital admission and phosphate administration
Feasibility as measured by the proportion of treatment-group participants receiving at least one infusion	Based on the prospective phosphate supplementation phase, determine the feasibility of developing a randomized controlled trial to assess safety and efficacy of phosphate treatment in patients with acute pancreatitis.	Up to 3 months post-discharge
Feasibility as measured by the proportion of treatment-group participants completing treatment	Based on the prospective phosphate supplementation phase, determine the feasibility of developing a randomized controlled trial to assess safety and efficacy of phosphate treatment in patients with acute pancreatitis.	Up to 3 months post-discharge

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Samuel Francis, MD, Duke University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Pancreas; Hyperphosphatemia; Phosphate; Hypophosphatemia; Pancreatitis; Sodium Phosphate; Potassium Phosphate
• Additional Relevant MeSH Terms: Metabolic Diseases; Digestive System Diseases; Pancreatic Diseases; Phosphorus Metabolism Disorders; Nutritional and Metabolic Diseases; Pancreatitis; Hypophosphatemia; Hyperphosphatemia; sodium phosphate; potassium phosphate
• Other Study ID Numbers: Pro00120087; 1R01DK142980-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No