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This study was terminated when the P.I. left the university.
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No nitric oxide | No Intervention | This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics | |
| Nitric Oxide | Experimental | Will receive Nitric oxide and other standard inhaled anesthetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if Inhaled Nitric Oxide Has Beneficial Effects on Overall Outcome After Extended Criteria Donor (EDC) Liver Transplantation | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To Construct a Plasma Metabolic/Protein Profile of I/R Injury in Transplanted Livers | 3 years | |
| To Examine the Effects of Nitric Oxide on Protein Synthesis and Metabolism Following Extended Criteria Donor Liver Transplantation | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Fiegel, M.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Nitric Oxide | This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics |
| FG001 | Nitric Oxide | Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics data was not collected one participant whose sample was invalid.
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| ID | Title | Description |
|---|---|---|
| BG000 | No Nitric Oxide | This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics |
| BG001 | Nitric Oxide | Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine if Inhaled Nitric Oxide Has Beneficial Effects on Overall Outcome After Extended Criteria Donor (EDC) Liver Transplantation | The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data. | Posted | 3 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Nitric Oxide | This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Naughton | University of Colorado Denver | 303-724-0833 | nick.naughton@cuanschutz.edu |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diagnosis | Number | participants |
|
| Model for End-Stage Liver Disease Score | The Model For End-Stage Liver Disease (MELD) score assesses the severity of patient liver disease. Possible scores range from 6 to 40, with higher scores indicating more severe liver disease and a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
| Secondary | To Construct a Plasma Metabolic/Protein Profile of I/R Injury in Transplanted Livers | The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data. | Posted | 3 years |
|
|
| Secondary | To Examine the Effects of Nitric Oxide on Protein Synthesis and Metabolism Following Extended Criteria Donor Liver Transplantation | The outcome measure data are unavailable. This study was terminated when the P.I. left the university. Research Administration and the study team have made numerous unsuccessful attempts to obtain the outcome measure data. | Posted | 3 years |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Nitric Oxide | Will receive Nitric oxide and other standard inhaled anesthetics Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery | 0 | 7 | 0 | 7 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |