Recruiting
Phase 2

Phosphate

Sponsor:

Duke University

Code:

NCT07681050

Conditions

Pancreatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Phosphate

Potassium Phosphate

Study Details

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

Study ID

NCT07681050

Start date

Jul 9, 2026

Status verified date

Jul, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • Serum Phosphorus Levels [ Time Frame: During hospitalization, up to approximately 7 days ]
  • Disease Severity as measured by the Revised Atlanta Classification (RAC) [ Time Frame: During hospitalization, up to approximately 7 days ]

Central Contacts and Locations

Central contacts

Samuel Francis, MD

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

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Lezly Collins

lezly.collins@duke.edu

Principal Investigator:

Samuel Francis, MD

More Information

Sponsor

Duke University

Last update posted

Aug 26, 2026

Last verified

Jul, 2026

Keywords

  • Pancreas
  • Pancreatitis
  • Phosphate
  • Hypophosphatemia
  • Hyperphosphatemia
  • Sodium Phosphate
  • Potassium Phosphate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-08-26.