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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
| University of Washington | OTHER |
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This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.
Specifically, presenting ischemia-reperfusion injury to transplanted livers remains a therapeutic goal in improving liver function and potentially expanding the number of transplantable livers. This study aims to assess the efficacy of inhaled nitric oxide to limit ischemia-reperfusion injury in transplanted livers and by doing so improve liver function post transplantation and decrease patient hospital length of stays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Experimental | Experimental | iNO administration |
|
| 2. Placebo | Placebo Comparator | Placebo (nitrogen) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled nitric oxide | Drug | inhaled 80ppm for duration of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels) | The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline). | baseline and 96 hours after baseline |
| Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels) | The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline). | baseline and 96 hours after baseline |
| Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels) | The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease. | baseline and 96 hours after baseline |
| Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT)) | The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. | baseline and 96 hours after baseline |
| Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of iNO on Hosptial Length of Stay | number of days subject in hospital after surgery until discharge | from surgery through discharge from hospital |
| Effect of iNO on SICU Stay | Number of minutes after surgery subject remained in SICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh P Patel, PhD | University of Alabama at Birmingham | Principal Investigator |
| Keith A Jones, MD | University of Alabama at Birmingham | Principal Investigator |
| Devin E Eckhoff, MD | University of Alabama at Birmingham | Principal Investigator |
| John S Bynon, MD | University of Alabama at Birmingham | Study Director |
| Blair Smith, MD | University of Alabama at Birmingham | Study Director |
| Clark Cross, MD | University of Alabama at Birmingham | Study Chair |
| Luc Frenette, MD | University of Alabama at Birmingham | Study Director |
| John D Lang, MD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17717604 | Background | Lang JD Jr, Teng X, Chumley P, Crawford JH, Isbell TS, Chacko BK, Liu Y, Jhala N, Crowe DR, Smith AB, Cross RC, Frenette L, Kelley EE, Wilhite DW, Hall CR, Page GP, Fallon MB, Bynon JS, Eckhoff DE, Patel RP. Inhaled NO accelerates restoration of liver function in adults following orthotopic liver transplantation. J Clin Invest. 2007 Sep;117(9):2583-91. doi: 10.1172/JCI31892. | |
| 24533048 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1. Experimental | iNO administration inhaled nitric oxide : inhaled 80ppm for duration of surgery. |
| FG001 | 2. Placebo | Placebo (nitrogen) nitrogen gas : inhaled |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide | 80 ppm was administered by inhalation for the duration of surgery |
| BG001 | Placebo (Nitrogen Gas) | 80 ppm was administered by inhalation for the duration of surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels) | The faster the percent decrease of AST reflect the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. The rate was calculated by measuring AST levels at baseline and at 96 hours post baseline. (AST levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of AST relative to baseline). | Posted | Mean | Standard Deviation | percentage change from baseline | baseline and 96 hours after baseline |
|
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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 | 1. Experimental | iNO administration inhaled nitric oxide : inhaled 80ppm for duration of surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rakesh Patel | University of Alabama at Birmingham | 205-934-3411 | rakeshp@uab.edu |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D009584 | Nitrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| nitrogen gas | Drug | inhaled |
|
A positive percent reflects an decrease; a negative percentage reflects a increase. |
| baseline and 96 hours after baseline |
| Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications) | Number of complications due to hepatobiliary events. | baseline to 9 months after transplantation |
| Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery | Number of any complication reported by subjects at 9 months after surgery | baseline to 9 months post surgery |
| baseline to discharge for SICU |
| Seattle |
| Washington |
| 98195-6540 |
| United States |
| Derived |
| Lang JD Jr, Smith AB, Brandon A, Bradley KM, Liu Y, Li W, Crowe DR, Jhala NC, Cross RC, Frenette L, Martay K, Vater YL, Vitin AA, Dembo GA, Dubay DA, Bynon JS, Szychowski JM, Reyes JD, Halldorson JB, Rayhill SC, Dick AA, Bakthavatsalam R, Brandenberger J, Broeckel-Elrod JA, Sissons-Ross L, Jordan T, Chen LY, Siriussawakul A, Eckhoff DE, Patel RP. A randomized clinical trial testing the anti-inflammatory effects of preemptive inhaled nitric oxide in human liver transplantation. PLoS One. 2014 Feb 12;9(2):e86053. doi: 10.1371/journal.pone.0086053. eCollection 2014. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Effect of iNO on Hosptial Length of Stay | number of days subject in hospital after surgery until discharge | Posted | Mean | Inter-Quartile Range | days | from surgery through discharge from hospital |
|
|
|
| Primary | Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels) | The faster the percent decrease ALT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. . (ALT levels were lower at 96 hours relative to baseline- positive values in data table indicate percent decrease of ALT relative to baseline). | Posted | Mean | Standard Deviation | percentage change from baseline | baseline and 96 hours after baseline |
|
|
|
| Primary | Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels) | The faster the percent increase of alkaline phosphatase reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an increase; a negative percentage reflects a decrease. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline and 96 hours after baseline |
|
|
|
| Primary | Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT)) | The faster the percent increase of PT reflect, the greater the treatment improved liver function post transplant. A positive percent reflects an decrease; a negative percentage reflects a increase. | Posted | Mean | Standard Deviation | percentage change from baseline | baseline and 96 hours after baseline |
|
|
|
| Primary | Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels) | A positive percent reflects an decrease; a negative percentage reflects a increase. | Posted | Mean | Standard Deviation | percent change from baseline | baseline and 96 hours after baseline |
|
|
|
| Secondary | Effect of iNO on SICU Stay | Number of minutes after surgery subject remained in SICU | Posted | Mean | Inter-Quartile Range | minutes | baseline to discharge for SICU |
|
|
|
| Primary | Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications) | Number of complications due to hepatobiliary events. | Posted | Number | Complications | baseline to 9 months after transplantation |
|
|
|
| Primary | Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery | Number of any complication reported by subjects at 9 months after surgery | Posted | Number | complications | baseline to 9 months post surgery |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 2. Placebo | Placebo (nitrogen) nitrogen gas : inhaled | 1 | 39 | 0 | 39 |
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| D013568 | Pathological Conditions, Signs and Symptoms |