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Parenteral Ascorbic Acid Repletion in TransplantatIon

Study acronym: PARTI
StatusWithdrawn
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Suspended → Withdrawn Show 4 more changesShow less
    • Enrollment target: estimated 90 to confirmed 0
    • Sponsor's reason: Resources to Staffing patterns
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Start date: May 2026 to Sep 2026v43
  3. Start date: Mar 2026 to May 2026v42
  4. Primary completion date: Jan 2031 to Mar 2031
    • Study completion date: Jan 2032 to Mar 2032
    • Start date: Jan 2026 to Mar 2026
    v41
  5. Trial status: Recruiting to Suspended Sponsor's reason: Resourcesv40 Show 4 more changesShow less
    • Primary completion date: Jan 2030 to Jan 2031
    • Start date: Oct 2025 to Jan 2026
    • Study completion date: Jan 2031 to Jan 2032
    • Site details revised
Show 38 earlier versionsHide 38 earlier versions
  1. Start date: Sep 2025 to Oct 2025v39
  2. Start date: Jul 2025 to Sep 2025
    • Site contact updated
    v38
  3. Start date: Jun 2025 to Jul 2025v37
  4. Start date: May 2025 to Jun 2025
    • Site contact updated
    v36
  5. Start date: Apr 2025 to May 2025
    • Site contact updated
    v35
  6. Start date: Mar 2025 to Apr 2025v34
  7. Start date: Feb 2025 to Mar 2025v33
  8. Start date: Jan 2025 to Feb 2025
    • Site contact updated
    v32
  9. Primary completion date: Dec 2029 to Jan 2030
    • Study completion date: Dec 2030 to Jan 2031
    • Start date: Dec 2024 to Jan 2025
    v31
  10. Start date: Nov 2024 to Dec 2024
    • Site contact updated
    v30
  11. Start date: Oct 2024 to Nov 2024v29
  12. Start date: Sep 2024 to Oct 2024v28
  13. Start date: Aug 2024 to Sep 2024v27
  14. Primary completion date: Dec 2025 to Dec 2029
    • Study completion date: Dec 2026 to Dec 2030
    • Site contact updated
    v26
  15. Start date: Jul 2024 to Aug 2024v25
  16. Start date: Jun 2024 to Jul 2024v24
  17. Start date: May 2024 to Jun 2024v23
  18. Start date: Mar 2024 to May 2024v22
  19. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v21
  20. Start date: Jan 2024 to Mar 2024v20
  21. Start date: Nov 2023 to Jan 2024v19
  22. Start date: Sep 2023 to Nov 2023v18
  23. Start date: Jun 2023 to Sep 2023v17
  24. Start date: Apr 2023 to Jun 2023v16
  25. Start date: Mar 2023 to Apr 2023v15
  26. Start date: Jan 2023 to Mar 2023v14
  27. Start date: Dec 2022 to Jan 2023v13
  28. Start date: Oct 2022 to Dec 2022v12
  29. Start date: Sep 2022 to Oct 2022v11
  30. Start date: Jun 2022 to Sep 2022v10
  31. Start date: Apr 2022 to Jun 2022v9
  32. Start date: Feb 2022 to Apr 2022v8
  33. Start date: Jan 2022 to Feb 2022v7
  34. Start date: Dec 2021 to Jan 2022v6
  35. Re-verified, no change to tracked fieldsv5
  36. Start date: Oct 2021 to Dec 2021
    • Primary completion date: Jul 2025 to Dec 2025
    • Study completion date: Jul 2026 to Dec 2026
    v4
  37. Start date: Sep 2021 to Oct 2021v3
  38. Start date: Jul 2021 to Sep 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04756063
Lead Sponsor University of Wisconsin, Madison
Conditions
(from sponsor)		 Liver Transplant Failure and Rejection
Related terms Rejection, Psychology
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov