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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK142980-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to injectable phosphate including:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Francis, MD | Contact | 919-684-5537 | samuel.francis@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Francis, MD | Duke University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D017674 | Hypophosphatemia |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C018279 | sodium phosphate |
| C013216 | potassium phosphate |
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| 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. |
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| 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 |
| D009750 | Nutritional and Metabolic Diseases |