Phosphate in Acute Pancreatitis
ConditionPancreatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Hyperkalemia
Hypercalcemia or significant hypocalcemia
Severe renal impairment (eGFR <30 mL/min/1.73m2) or end-stage renal disease
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium Phosphate
DrugThe 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
DrugThis 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Standard of Care Observational PhaseNo intervention 0 interventions
Group B: Phosphate Treatment PhaseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 days2
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 daysSecondary outcomes
1
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 administration2
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-discharge3
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-dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Duke University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov