Phosphate in Acute Pancreatitis

NCT07681050 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: Pro001200871R01DK142980-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreatitis

Keywords

Pancreas; Pancreatitis; Phosphate; Hypophosphatemia; Hyperphosphatemia; Sodium Phosphate; Potassium Phosphate

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Dosing Requirements

  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

  Up to 3 months post-discharge

• Feasibility as measured by the proportion of treatment-group participants completing treatment

  Up to 3 months post-discharge

Study Arms (2)

Standard of Care Observational Phase

NO INTERVENTION

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.

Phosphate Treatment Phase

EXPERIMENTAL

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; Drug: Potassium Phosphate

Interventions

Sodium Phosphate DRUG

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.

Also known as: Sodium Phosphate Injection, USP, 3mM P/mL

Phosphate Treatment Phase

Potassium Phosphate DRUG

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.

Also known as: Potassium Phosphates Injection

Phosphate Treatment Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindications to injectable phosphate including:
• Hyperkalemia
• Hypercalcemia or significant hypocalcemia
• Severe renal impairment (eGFR \<30 mL/min/1.73m2) or end-stage renal disease

Sponsors & Collaborators

• Duke University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Hypophosphatemia; Hyperphosphatemia

Interventions

sodium phosphate; potassium phosphate

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Samuel Francis, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Francis, MD

CONTACT

919-684-5537; samuel.francis@duke.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)