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Vitamin

High-Dose Vitamin C for Liver Transplant Care (PARTI Trial)

Phase 4

Recruiting

Led By Molly Groose, MD, MS

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The subject is scheduled to undergo primary deceased donor solidary liver transplantation

Be older than 18 years old

Must not have

Non-English speaking

Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative (up to ~ 7 days)

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will test whether giving supraphysiologic doses of ascorbic acid (vitamin C) to patients undergoing liver transplantation will improve outcomes.

Who is the study for?

This trial is for adults set to have their first liver transplant from a deceased donor. It's not for prisoners, those with decision-making impairments, allergies to vitamin C, certain blood disorders like G6PD deficiency or sickle cell anemia, kidney issues including stones or high creatinine without dialysis, pregnant individuals, non-English speakers, or anyone on other trials.

What is being tested?

The study tests if high doses of vitamin C given through IV can help patients after liver transplants better than a saltwater placebo. Participants are randomly chosen to get either the vitamin C treatment every 6 hours for two days or the placebo. Doctors will check if there's any improvement in organ failure scores and monitor other health outcomes.

What are the potential side effects?

Potential side effects may include complications related to high doses of vitamin C such as kidney stones in susceptible individuals and possibly upset stomach or diarrhea. Since it's administered intravenously, there might also be reactions at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a liver transplant from a deceased donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I have G6PD deficiency.

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My creatinine levels are above 2.5mg/dL and I am not on dialysis.

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I do not have a condition that affects my ability to make decisions.

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I am undergoing or have undergone a simultaneous organ transplant.

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I have received amino acid supplements through injections or orally.

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I am scheduled for a procedure that will use a veno-venous bypass.

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I have hereditary hemochromatosis.

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I have had kidney stones or high oxalate levels in my urine.

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I have sickle cell anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative (up to ~ 7 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative (up to ~ 7 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative (up to ~ 7 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Sequential Organ Failure Assessment (SOFA) Score

Secondary study objectives

Incidence of Early Graft Dysfunction

Incidence of Infection

Postoperative Day 7 SOFA Score

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ascorbic Acid (AA)Experimental Treatment1 Intervention

The first intravenous dosage of 1500mg of AA in 100mL of normal saline (NS) will be administered after induction of general anesthesia and invasive line placement prior to surgical incision. An identical dosage will be delivered approximately every 6 hours for the first 48 hours, for a total of 8 doses

Group II: PlaceboPlacebo Group1 Intervention

The first intravenous dosage of placebo (100 mL of NS) will be administered after induction of general anesthesia and invasive line placement prior to surgical incision. An identical dosage will be delivered approximately every 6 hours for the first 48 hours, for a total of 8 doses

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ascorbic acid

2018

Completed Phase 4

~650

0 / 11Eligibility criteria met