Liver Transplant Failure and RejectionPhase 4PARTINCT04756063
Parenteral Ascorbic Acid Repletion in TransplantatIon
A Phase 4 study testing Ascorbic acid in people with Liver Transplant Failure and Rejection, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Transplant Failure and Rejection
- What is being tested?
- Ascorbic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2032
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is scheduled to undergo primary deceased donor solidary liver transplantation
Who cannot join
- Non-English speaking
- Known or believed to be pregnant
- Subject is a prisoner
- Impaired decision-making capacity (i.e., current encephalopathy)
- Known allergy to AA
- Concurrent organ transplantation (i.e., simultaneous liver-kidney transplantation)
Show all 15Show fewer
- Planned veno-venous bypass use in the operating room
- Prior parenteral or oral AA repletion
- History of nephrolithiasis or oxaluria
- Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Sickle cell anemia
- Hereditary hemochromatosis
- Preoperative anuria or creatinine >2.5mg/dL in patient not on renal replacement therapy
- Current enrollment in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI): A Randomized, Double-Blinded, Placebo-Controlled Trial
A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation. Participants randomized to the intervention group will receive intravenous (IV) AA 1500 mg every 6 hours for 48 hours. Participants randomized to the control group will receive a saline placebo. The primary study outcome will be a change in the Sequential Organ Failure Assessment (SOFA) score from baseline to three days after the first dose of drug (dSOFA3). Secondary outcomes will include total vasopressor dose in norepinephrine equivalents, 30-day and 1-year mortality, and serum AA levels.
Read the detailed description
HYPOTHESIS: Administration of supraphysiologic doses of parenteral AA in the perioperative period for patients undergoing liver transplantation will improve Sequential Organ Failure Assessment (SOFA) scores, vasopressor usage and biochemical, cellular and clinical end-organ damage.
Specific Aim: Determine the clinical response to parenteral AA supplementation in patients undergoing liver transplantation by a randomized, double-blinded, placebo-controlled clinical trial.
Study Design: This study is a prospective, single-center, randomized trial in which 90 participants will be enrolled at the University of Wisconsin Hospitals and Clinics (UWHC). Participants must meet study eligibility criteria and be scheduled to undergo primary deceased donor solitary liver transplantation. Participants will be randomized to receive 8 doses of 1500 mg AA IV or volume-equivalent placebo every 6 hours for 48 hours, in addition to standard medical management.
- Conditions
- Liver Transplant Failure and Rejection
- Being tested
- Ascorbic acid, Placebo
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic acidDrug
Also called vitamin C, ASCOR
Intravenous vitamin C
PlaceboOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Ascorbic Acid (AA) | Experimental | 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 Receives: Drug: Ascorbic acid |
| Placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sequential Organ Failure Assessment (SOFA) Score
SOFA scores are a widely used composite measure of multiorgan dysfunction, validated as an accurate predictor of short- and long-term mortality in the general ICU and liver transplant populations. Change in SOFA from baseline (delta SOFA or dSOFA) has been shown to be more predictive of mortality than other derivatives such as absolute interval SOFA scores and has been recommended as the preferred endpoint in critical care settings
The total possible range of scores is 0-24, higher scores are indicative of a higher degree of dysfunction.
Measured: baseline to 3 days after first dose
Secondary outcomes (10)
Serum AA Levels
Measured: Pre-treatment (baseline) and Post-treatment (up to 1 week)
Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram
Measured: from start of anesthesia (day 1) to end of ICU stay (up to 1 week)
Incidence of Early Graft Dysfunction
As defined per Olthoff as: total bilirubin ≥10 or INR≥1.6 on day 7, or transaminase >2000 within first 7 days
Measured: postoperative (up to 7 days or until discharge, whichever came first)
Postoperative Day 7 SOFA Score
Total range of scores 0-24 where higher scores indicate higher dysfunction.
Measured: postoperative (up to 3 days)
Days on Ventilator
Measured: postoperative (up to ~ 7 days)
Incidence of Infection
Surgical site, bloodstream \& intra-abdominal infection rates
Measured: postoperative (up to ~ 7 days)
Length of ICU stay
Measured: postoperative (up to ~ 7 days)
Length of Hospital stay
Measured: postoperative (up to ~ 30 days)
30 day Mortality
Measured: up to 30 days post-op
1-year Mortality
Measured: up to 1-year post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study startSep 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2032 (estimated)
Why it stopped: Staffing patterns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant Failure and RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Molly Groose, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756063
- Sponsor's protocol ID
- 2020-1153
- Other IDs
- A530900, SMPH/ANESTHESIOLOGY, Protocol Version 12/5/2024
- Acronym
- PARTI
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2021
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Molly Groose, the Principal Investigator of this study
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI): A Randomized, Double-Blinded, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04756063
- Acronym / sponsor ID
- PARTI / 2020-1153
- Conditions
- Liver Transplant Failure and Rejection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Staffing patterns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2032 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation. Participants randomized to the intervention group will receive intravenous (IV) AA 1500 mg every 6 hours for 48 hours. Participants randomized to the control group will receive a saline placebo. The primary study outcome will be a change in the Sequential Organ Failure Assessment (SOFA) score from baseline to three days after the first dose of drug (dSOFA3). Secondary outcomes will include total vasopressor dose in norepinephrine equivalents, 30-day and 1-year mortality, and serum AA levels.
Detailed description
HYPOTHESIS: Administration of supraphysiologic doses of parenteral AA in the perioperative period for patients undergoing liver transplantation will improve Sequential Organ Failure Assessment (SOFA) scores, vasopressor usage and biochemical, cellular and clinical end-organ damage.
Specific Aim: Determine the clinical response to parenteral AA supplementation in patients undergoing liver transplantation by a randomized, double-blinded, placebo-controlled clinical trial.
Study Design: This study is a prospective, single-center, randomized trial in which 90 participants will be enrolled at the University of Wisconsin Hospitals and Clinics (UWHC). Participants must meet study eligibility criteria and be scheduled to undergo primary deceased donor solitary liver transplantation. Participants will be randomized to receive 8 doses of 1500 mg AA IV or volume-equivalent placebo every 6 hours for 48 hours, in addition to standard medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascorbic Acid (AA) | Experimental | Drug: Ascorbic acidThe 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 |
| Placebo | Placebo comparator | Other: PlaceboThe 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The subject is scheduled to undergo primary deceased donor solidary liver transplantation
Key exclusion criteria (15 listed)
- Non-English speaking
- Known or believed to be pregnant
- Subject is a prisoner
- Impaired decision-making capacity (i.e., current encephalopathy)
- Known allergy to AA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic acidAlso: vitamin C, ASCORIntravenous vitamin C | Drug | Ascorbic Acid (AA) |
| PlaceboNormal Saline | Other | Placebo |
Primary outcome
Change in Sequential Organ Failure Assessment (SOFA) Score
Time frame: baseline to 3 days after first dose
SOFA scores are a widely used composite measure of multiorgan dysfunction, validated as an accurate predictor of short- and long-term mortality in the general ICU and liver transplant populations. Change in SOFA from baseline (delta SOFA or dSOFA) has been shown to be more predictive of mortality than other derivatives such as absolute interval SOFA scores and has been recommended as the preferred endpoint in critical care settings The total possible range of scores is 0-24, higher scores are indicative of a higher degree of dysfunction.
10 secondary outcomes
Serum AA Levels
Time frame: Pre-treatment (baseline) and Post-treatment (up to 1 week)
Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram
Time frame: from start of anesthesia (day 1) to end of ICU stay (up to 1 week)
Incidence of Early Graft Dysfunction
Time frame: postoperative (up to 7 days or until discharge, whichever came first)
Postoperative Day 7 SOFA Score
Time frame: postoperative (up to 3 days)
Days on Ventilator
Time frame: postoperative (up to ~ 7 days)
Incidence of Infection
Time frame: postoperative (up to ~ 7 days)
Length of ICU stay
Time frame: postoperative (up to ~ 7 days)
Length of Hospital stay
Time frame: postoperative (up to ~ 30 days)
30 day Mortality
Time frame: up to 30 days post-op
1-year Mortality
Time frame: up to 1-year post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. Data from this study may be requested from other researchers up to 7 years after the completion of the primary endpoint by contacting Dr. Molly Groose, the Principal Investigator of this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly Groose, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascorbic acid in people with Liver Transplant Failure and Rejection, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sequential Organ Failure Assessment (SOFA) Score (time frame: baseline to 3 days after first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.