A Phase 2 interventional study of Sodium Phosphate and Potassium Phosphate in Pancreatitis, sponsored by Duke University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Duke University · Phase 2, Interventional, and Treatment
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:
Participants will:
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to injectable phosphate including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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
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.
Time frame: 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.
Time frame: During hospitalization, up to approximately 7 days
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 months post-discharge
Plan to share: No
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Studies of the drugs tested here: Sodium phosphate · Potassium phosphate