Phosphate in Acute Pancreatitis

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

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.

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