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Phosphate in Acute Pancreatitis (PPP)

24 de agosto de 2026 actualizado por: Duke University

Phosphate in Acute Pancreatitis (PPP)

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

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Pancreatitis

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

100

Fase

Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Nombre: Samuel Francis, MD
Número de teléfono: 919-684-5537
Correo electrónico: samuel.francis@duke.edu

Ubicaciones de estudio

Estados Unidos
- North Carolina
  - Durham, North Carolina, Estados Unidos, 27710
    - Reclutamiento
    - Duke University Medical Center
    - Contacto:
      
      Lezly Collins
      
      Correo electrónico: lezly.collins@duke.edu
    - Investigador principal:
      
      Samuel Francis, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

Adulto
Adulto Mayor

Acepta Voluntarios Saludables

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: No aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Ninguno (etiqueta abierta)

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Sin intervención: 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.	Droga: 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. Otros nombres: Sodium Phosphate Injection, USP, 3mM P/mL Droga: 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. Otros nombres: Potassium Phosphates Injection

Grupo de participantes/brazo

Intervención / Tratamiento

Sin intervención: 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.

Droga: 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.

Otros nombres:

Sodium Phosphate Injection, USP, 3mM P/mL

Droga: 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.

Otros nombres:

Potassium Phosphates Injection

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Serum Phosphorus Levels Periodo de tiempo: 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.	During hospitalization, up to approximately 7 days
Disease Severity as measured by the Revised Atlanta Classification (RAC) Periodo de tiempo: 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.	During hospitalization, up to approximately 7 days

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Dosing Requirements Periodo de tiempo: 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.	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 Periodo de tiempo: 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.	Up to 3 months post-discharge
Feasibility as measured by the proportion of treatment-group participants completing treatment Periodo de tiempo: 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.	Up to 3 months post-discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Duke University

Colaboradores

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigadores

Investigador principal: Samuel Francis, MD, Duke University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

26 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de junio de 2026

Publicado por primera vez (Actual)

2 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

Pro00120087
1R01DK142980-01A1 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

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Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

producto fabricado y exportado desde los EE. UU.

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Phosphate in Acute Pancreatitis (PPP)