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| ID | Type | Description | Link |
|---|---|---|---|
| A530900 | Other Identifier | UW Madison | |
| SMPH/ANESTHESIOLOGY | Other Identifier | UW Madison | |
| Protocol Version 12/5/2024 | Other Identifier | UW Madison |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid | Drug | Intravenous vitamin C |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 3 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Serum AA Levels | Pre-treatment (baseline) and Post-treatment (up to 1 week) | |
| Total Vasopressor Dose in Norepinephrine Equivalents per Kilogram | from start of anesthesia (day 1) to end of ICU stay (up to 1 week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly Groose, MD, MS | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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
up to 7 years after primary completion
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Other | Normal Saline |
|
| 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 | 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. | postoperative (up to 3 days) |
| Days on Ventilator | postoperative (up to ~ 7 days) |
| Incidence of Infection | Surgical site, bloodstream & intra-abdominal infection rates | postoperative (up to ~ 7 days) |
| Length of ICU stay | postoperative (up to ~ 7 days) |
| Length of Hospital stay | postoperative (up to ~ 30 days) |
| 30 day Mortality | up to 30 days post-op |
| 1-year Mortality | up to 1-year post-op |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |