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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04756063




Registration number
NCT04756063
Ethics application status
Date submitted
11/02/2021
Date registered
16/02/2021
Date last updated
6/11/2024

Titles & IDs
Public title
Parenteral Ascorbic Acid Repletion in TransplantatIon
Scientific title
Parenteral Ascorbic Acid Repletion in TransplantatIon (PARTI): A Randomized, Double-Blinded, Placebo-Controlled Trial
Secondary ID [1] 0 0
A530900
Secondary ID [2] 0 0
2020-1153
Universal Trial Number (UTN)
Trial acronym
PARTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver Transplant Failure and Rejection 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ascorbic acid
Other interventions - Placebo

Experimental: Ascorbic Acid (AA) - 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

Placebo comparator: Placebo - 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: Drugs: Ascorbic acid
Intravenous vitamin C

Other interventions: Placebo
Normal Saline
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Sequential Organ Failure Assessment (SOFA) Score
Timepoint [1] 0 0
baseline to 3 days after first dose
Secondary outcome [1] 0 0
Serum AA Levels
Timepoint [1] 0 0
Pre-treatment (baseline) and Post-treatment (up to 1 week)
Secondary outcome [2] 0 0
Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram
Timepoint [2] 0 0
from start of anesthesia (day 1) to end of ICU stay (up to 1 week)
Secondary outcome [3] 0 0
Incidence of Early Graft Dysfunction
Timepoint [3] 0 0
postoperative (up to 7 days or until discharge, whichever came first)
Secondary outcome [4] 0 0
Postoperative Day 7 SOFA Score
Timepoint [4] 0 0
postoperative (up to 3 days)
Secondary outcome [5] 0 0
Days on Ventilator
Timepoint [5] 0 0
postoperative (up to ~ 7 days)
Secondary outcome [6] 0 0
Incidence of Infection
Timepoint [6] 0 0
postoperative (up to ~ 7 days)
Secondary outcome [7] 0 0
Length of ICU stay
Timepoint [7] 0 0
postoperative (up to ~ 7 days)
Secondary outcome [8] 0 0
Length of Hospital stay
Timepoint [8] 0 0
postoperative (up to ~ 30 days)
Secondary outcome [9] 0 0
30 day Mortality
Timepoint [9] 0 0
up to 30 days post-op
Secondary outcome [10] 0 0
1-year Mortality
Timepoint [10] 0 0
up to 1-year post-op

Eligibility
Key inclusion criteria
* The subject is scheduled to undergo primary deceased donor solidary liver transplantation
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Other
Name
University of Wisconsin, Madison
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/study/NCT04756063
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Molly Groose, MD, MS
Address 0 0
University of Wisconsin, Madison
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helen Akere
Address 0 0
Country 0 0
Phone 0 0
(608) 265-3243
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04756063