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Phosphate in Acute Pancreatitis (PPP)

24 augustus 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Werving

Conditie

Pancreatitis

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Samuel Francis, MD
Telefoonnummer: 919-684-5537
E-mail: samuel.francis@duke.edu

Studie Locaties

Verenigde Staten
- North Carolina
  - Durham, North Carolina, Verenigde Staten, 27710
    - Werving
    - Duke University Medical Center
    - Contact:
      
      Lezly Collins
      
      E-mail: lezly.collins@duke.edu
    - Hoofdonderzoeker:
      
      Samuel Francis, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling
Toewijzing: Niet-gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Geen tussenkomst: 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.
Experimenteel: 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.	Geneesmiddel: 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. Andere namen: Sodium Phosphate Injection, USP, 3mM P/mL Geneesmiddel: 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. Andere namen: Potassium Phosphates Injection

Deelnemersgroep / Arm

Interventie / Behandeling

Geen tussenkomst: 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.

Experimenteel: 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.

Geneesmiddel: 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.

Andere namen:

Sodium Phosphate Injection, USP, 3mM P/mL

Geneesmiddel: 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.

Andere namen:

Potassium Phosphates Injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Serum Phosphorus Levels Tijdsspanne: 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) Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Dosing Requirements Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Duke University

Medewerkers

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

Onderzoekers

Hoofdonderzoeker: Samuel Francis, MD, Duke University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juli 2026

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 januari 2029

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

Pro00120087
1R01DK142980-01A1 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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Phosphate in Acute Pancreatitis (PPP)