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NCT00948194 · ClinicalTrials.gov registry record · NA
Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation
A NA study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT00948194 is a NA study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 13 participants.
The verdict
NCT00948194, a NA study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the donor graft. In reviewing the literature, no uniform extended criteria donor classification exists. The characteristics most associated with liver graft failure appear to be cold ischemia time greater than 10 hours, warm ischemia time greater than 40 minutes, donor age \> 55 years of age, donor hospitalization \> 5 days, a donation after cardiac death (DCD) graft, and a split graft. The researchers will exclude warm ischemia time as this is impossible to predict prior to the transplantation. Any donor meeting at least one of the other criteria will be classified as an EDC donor. Hypothesis 1: Inhaled nitric oxide will improve overall outcome of liver recipients after EDC liver transplantation * Suppression of oxidative injury will improve graft function postoperatively as measured by International Normalized Ratio (INR) bilirubin, transaminases, and duration of hospital stay. Hypothesis 2: The mechanisms of therapeutic efficacy of inhaled nitric oxide is based on reduction in post-reperfusion oxidative injury as readily measured by the detectable changes in the protein and metabolic profiles in plasma of patients treated with inhaled-NO * Nuclear Magnetic Resonance (NMR)-based metabolic markers (xanthine end-products, lactate, and hepatic osmolytes) that are consistent with acute liver injury will be decreased in NO-treated recipients. * Protein markers of reperfusion injury (argininosuccinate synthase (ASS) and estrogen sulfotransferase (EST-1) will be greater in the plasma of patients who are not treated with inhaled-NO * Reduced oxidative injury will be reflected by a decrease in the number of mitochondrial peroxiredoxins isoforms and the number that are oxidized
Interventions
- DRUG Nitric Oxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-10 |
| Est. Completion | 2015-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00948194
The ClinicalTrials.gov registry entry for NCT00948194 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nitric Oxide is the first listed.
NCT00948194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00948194 about?
NCT00948194 is a clinical study titled "Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation". In this study, the researchers propose to investigate the efficacy of inhaled nitric oxide to prevent ischemia-reperfusion (I/R) hepatocyte injury in patients who receive extended donor criteria(EDC)liver grafts based on changes in proteomic and metabolomic markers following revascularization of the...
What is the current status of trial NCT00948194?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2009-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00948194?
The interventions under investigation include: Nitric Oxide (DRUG).
Who is sponsoring clinical trial NCT00948194?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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