Pancreatitis
Conditions
Keywords
Pancreas, Pancreatitis, Phosphate, Hypophosphatemia, Hyperphosphatemia, Sodium Phosphate, Potassium Phosphate
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
Detailed description
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.
Interventions
DRUGSodium 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.
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.
Sponsors
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Phosphorus Levels | During hospitalization, up to approximately 7 days | Serum phosphorus levels measured in a control (observational) group of patients with acute pancreatitis. This will be determined utilizing the Revised Atlanta Classification. |
| Disease Severity as measured by the Revised Atlanta Classification (RAC) | During hospitalization, up to approximately 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosing Requirements | During the first 72 hours of hospital admission and phosphate administration | 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. |
| Feasibility as measured by the proportion of treatment-group participants receiving at least one infusion | Up to 3 months post-discharge | 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. |
| Feasibility as measured by the proportion of treatment-group participants completing treatment | Up to 3 months post-discharge | 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. |
Countries
United States
Contacts
CONTACTSamuel Francis, MD
PRINCIPAL_INVESTIGATORSamuel Francis, MD
Duke University Hospital
Outcome results
None listed