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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1-year post-op
Awards & highlights
PARTI 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.Check my eligibility
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.See study design
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.
PARTI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a liver transplant from a deceased donor.
PARTI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1-year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1-year post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Sequential Organ Failure Assessment (SOFA) Score
Secondary outcome measures
1-year Mortality
30 day Mortality
Days on Ventilator
+7 morePARTI 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
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,456 Total Patients Enrolled
Molly Groose, MD, MSPrincipal InvestigatorUniversity of Wisconsin, Madison
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.You are allergic to AA.I have G6PD deficiency.My creatinine levels are above 2.5mg/dL and I am not on dialysis.I am scheduled for a liver transplant from a deceased donor.I do not have a condition that affects my ability to make decisions.I am undergoing or have undergone a simultaneous organ transplant.I have received amino acid supplements through injections or orally.I am scheduled for a procedure that will use a veno-venous bypass.I have not taken Vitamin C supplements or received HAT therapy in the last month.I have hereditary hemochromatosis.I have had kidney stones or high oxalate levels in my urine.I have sickle cell anemia.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Ascorbic Acid (AA)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment extend its inclusion criteria to elderly participants?
"This medical study is seeking participants aged between 18 and 80 years old."
Answered by AI
Who would be the ideal candidates to volunteer for this experiment?
"This medical research is in search of 90 individuals between the ages 18 and 80, who have experienced therapeutic immunosuppression. Moreover, these participants must also be prepping for a deceased donor solidary liver transplantation procedure."
Answered by AI
What is the population size of this research endeavor?
"This study is no longer taking on new participants. It was initially posted in December 2022 and the last update was October 24th of that same year. If you're searching for other trials, there are 2 active studies related to therapeutic immunosuppression and 53 actively recruiting patients who will be given ascorbic acid."
Answered by AI
Are individuals still being enrolled into this experiment?
"According to the listing on clinicaltrials.gov, this trial is not currently accepting participants. Initially posted in December 1st 2022 and updated most recently on October 24th 2022, there are 55 other studies recruiting at present instead of this one."
Answered by AI
What medical concerns does Ascorbic acid typically address?
"Ascorbic acid is a remedy for ailments such as deficiency, vitamin A insufficiency and catarrh."
Answered by AI
Has the FDA endorsed Ascorbic acid for use?
"The safety of Ascorbic acid is highly regarded due to this Phase 4 trial, which gave it a score of 3."
Answered by AI
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