An interventional study of Nitric Oxide in Liver Transplantation, Ischemia/Reperfusion Injury and Oxidative Injury, sponsored by University of Colorado, Denver. Terminated at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's enrollment of 13 is below the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This arm will not receive nitric oxide, but will receive other standard inhaled anesthetics
Will receive Nitric oxide and other standard inhaled anesthetics
Drug: Nitric Oxide
Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery
Also known as: INOmax
To Determine if Inhaled Nitric Oxide Has Beneficial Effects on Overall Outcome After Extended Criteria Donor (EDC) Liver Transplantation
Time frame: 3 years
To Construct a Plasma Metabolic/Protein Profile of I/R Injury in Transplanted Livers
Time frame: 3 years
To Examine the Effects of Nitric Oxide on Protein Synthesis and Metabolism Following Extended Criteria Donor Liver Transplantation
Time frame: 3 years
| Milestone | No Nitric Oxide | Nitric Oxide |
|---|---|---|
| Started | 6 | 7 |
| Completed | 5 | 7 |
| Not completed | 1 | 0 |
| Withdrew: Blood drawn using incorrect test tube; sample invalid | 1 | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Nitric Oxide | — | 0/5 (0%) | 0/5 (0%) |
| Nitric Oxide | — | 0/7 (0%) | 0/7 (0%) |
Baseline characteristics data was not collected one participant whose sample was invalid.
| Age, Categorical(Participants) | No Nitric Oxide | Nitric Oxide | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 7 | 11 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | No Nitric Oxide | Nitric Oxide | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 4 | 5 | 9 |
| Diagnosis(participants) | No Nitric Oxide | Nitric Oxide | Total |
|---|---|---|---|
| Cirrhosis | 5 | 3 | 8 |
| Hepatitis C | 4 | 4 | 8 |
| HCC | 2 | 4 | 6 |
| Hepatoma | 1 | 4 | 5 |
| Primary Sclerosing Cholangitis (PSC) | 0 | 1 | 1 |
| Fatty Liver (NASH) | 1 | 0 | 1 |
| Metabolic Disease (METDIS) - Alpha-1-Antitrypsin Deficiency (A-1-A) | 0 | 1 | 1 |
| Bone mets | 0 | 1 | 1 |
| Model for End-Stage Liver Disease Score(units on a scale) | No Nitric Oxide | Nitric Oxide | Total |
|---|---|---|---|
| Mean | 26.2 ± 5.42 | 27.14 ± 3.64 | 26.75 ± 4.5 |
| BMI(kg/m^2) | No Nitric Oxide | Nitric Oxide | Total |
|---|---|---|---|
| Mean | 26.59 ± 5.01 | 27.1 ± 5.83 | 26.89 ± 5.51 |
This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver