Phosphate in Acute Pancreatitis

Официальное название

Phosphate in Acute Pancreatitis (PPP)

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Serum Phosphorus Levels [Срок оценки: During hospitalization, up to approximately 7 days]
• Disease Severity as measured by the Revised Atlanta Classification (RAC) [Срок оценки: During hospitalization, up to approximately 7 days]

Вторичные конечные точки (3)

• Dosing Requirements [Срок оценки: 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 [Срок оценки: Up to 3 months post-discharge]
• Feasibility as measured by the proportion of treatment-group participants completing treatment [Срок оценки: Up to 3 months post-discharge]

Критерии участия

Критерии включения

• 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

Критерии исключения

Contraindications to injectable phosphate including:

• Hyperkalemia
• Hypercalcemia or significant hypocalcemia
• Severe renal impairment (eGFR <30 mL/min/1.73m2) or end-stage renal disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Duke University Medical Center — Durham

Идентификаторы

NCT: NCT07681050 · Pro00120087 · 1R01DK142980-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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