100 Participants NeededMy employer runs this trial

Phosphate for Pancreatitis

(PPP Trial)

SF
Overseen BySamuel Francis, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering phosphate through an IV can help treat acute pancreatitis, a condition that causes sudden inflammation in the pancreas, by making it less severe. Researchers aim to determine if low phosphate levels increase the risk of this illness and if phosphate can improve its management. Participants will receive either standard care or an IV phosphate treatment (using Potassium Phosphate or Sodium Phosphate) and will undergo regular blood tests. This study targets adults who arrive at the Duke University Hospital emergency department with severe abdominal pain and meet specific lab criteria for pancreatitis. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that phosphate plays a crucial role in healing from acute pancreatitis, a sudden swelling of the pancreas. It aids in cell repair after damage. Some studies suggest that low phosphate levels can worsen pancreatitis. Experiments have demonstrated that adding phosphate can reduce the severity of the condition.

For safety, the researchers are examining two types of phosphate: potassium phosphate and sodium phosphate. Careful administration of these treatments is essential. Reports indicate that incorrect administration of potassium phosphate can cause serious issues. However, when used properly, phosphate is generally safe.

Overall, while research suggests that phosphate might help treat pancreatitis, it must be administered carefully to ensure safety. This study aims to explore the safe and effective use of phosphate therapy.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about using phosphate treatments for pancreatitis because they offer a novel approach by directly targeting phosphorus levels in the body. Unlike standard treatments that primarily focus on managing symptoms and providing supportive care, these phosphate infusions aim to correct hypophosphatemia, which can be common in pancreatitis patients. The continuous administration of sodium or potassium phosphate, adjusted based on the patient's serum phosphorus levels, could potentially stabilize the patient's condition more rapidly and effectively during their hospital stay. This targeted approach and its potential for quicker intervention make it a promising option in managing acute pancreatitis.

What evidence suggests that phosphate treatment might be effective for acute pancreatitis?

Research has shown that phosphate levels can affect acute pancreatitis, a sudden swelling of the pancreas. Some studies have found that low phosphate levels, known as hypophosphatemia, might worsen the condition. In animal studies, adding phosphate reduced the severity of pancreatitis. Maintaining normal phosphate levels aids cell repair after injury, potentially supporting recovery. In this trial, participants in the Phosphate Treatment Phase will receive sodium phosphate or potassium phosphate to assess potential benefits. Although limited information exists on phosphate treatment's effectiveness for humans with acute pancreatitis, these findings suggest it might help manage the condition.36789

Who Is on the Research Team?

SF

Samuel Francis, MD

Principal Investigator

Duke University Hospital

Are You a Good Fit for This Trial?

This trial is for adults with acute pancreatitis who come to the emergency department at Duke University Hospital. People are included if they have low or high phosphate levels, but specific inclusion and exclusion details aren't listed.

Inclusion Criteria

I am 18 years old or older.
I have acute pancreatitis with at least two key symptoms or test results.
I am able to give consent or have a legal representative who can do so for me.
See 1 more

Exclusion Criteria

I cannot safely receive injectable phosphate due to high potassium or other reasons.
I cannot safely receive injectable phosphate due to calcium level issues.
I do not have severe kidney problems or end-stage kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Observational Phase

Participants in the control group receive usual care with fluid resuscitation and have serum phosphorus levels checked every 6 hours during hospitalization.

Up to 7 days
Daily monitoring during hospital stay

Treatment Phase

Participants in the treatment group receive continuous intravenous phosphate infusions to maintain high-normal serum phosphorus levels during the first 72 hours of hospitalization.

Up to 72 hours
Continuous monitoring during hospital stay

Follow-up

Participants complete follow-up assessments post-discharge to evaluate illness severity and effects of phosphate supplementation.

Up to 3 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Potassium Phosphate
  • Sodium Phosphate

Trial Overview

The study is testing whether giving phosphate through an IV (either sodium or potassium phosphate) can help treat acute pancreatitis compared to standard care. Participants will be monitored during their hospital stay and after discharge.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Phosphate Treatment PhaseExperimental Treatment2 Interventions
Group II: Standard of Care Observational PhaseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

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

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Serum phosphate is associated with mortality among patients ...

This study found that serum phosphate value greater than 3.78 mg/dl within the first 24 h after admission in the ICU could predict mortality (area under curve = ...

Phosphate in Acute Pancreatitis

The goal of this study is to learn if phosphate administration works to treat acute pancreatitis in adults presenting to the emergency ...

Admission hyperphosphatemia as a predictor of severity ...

Clinical outcomes included severe AP (SAP), pancreatic necrosis, intensive care unit (ICU) admission, and 30-day all-cause mortality.

Severe Hypophosphatemia in a Patient with Acute Pancreatitis

We describe a patient with alcoholinduced pancreatitis who developed severe life-threatening hypophosphatemia of multifactorial origin during hospitalization.

The association between phosphate level at admission ...

Conclusion: Hyperphosphatemia at admission was independently associated with increased 30-day mortality in patients with acute pancreatitis. Hypophosphatemia at ...

Admission hyperphosphatemia as a predictor of severity and ...

Admission hyperphosphatemia independently predicts severe disease, pancreatic necrosis, ICU admission, and early mortality, highlighting a simple and ...

Hypophosphatemia as a Predictor of Clinical Outcomes in...

We additionally found that minimum phosphate levels differed significantly by severity of pancreatitis with median minimum phosphate of 2.3 mg/dL ...

Serum phosphate is associated with mortality among ...

In this large cohort, we identified baseline serum phosphate as the most valuable single routine laboratory test for predicting mortality in AP.

Hypophosphatemia as a Predictor of Clinical Outcomes ... - PMC

Phosphate is crucial for cellular repair after injury and may be important in recovery following acute pancreatitis (AP).