Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 19 yr of age scheduled to undergo liver transplantation.
排除标准
- •Patients < 19 yr of age
- •Patients undergoing re-transplantation or dual organ transplantation
- •Patients with underlying pulmonary complications
研究组 & 干预措施
1. Experimental
iNO administration
干预措施: inhaled nitric oxide (Drug)
2. Placebo
Placebo (nitrogen)
干预措施: nitrogen gas (Drug)
结局指标
主要结局
Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery
时间窗: baseline to 9 months post surgery
Number of any complication reported by subjects at 9 months after surgery
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)
时间窗: baseline and 96 hours after baseline
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).
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)
时间窗: baseline and 96 hours after baseline
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).
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))
时间窗: baseline and 96 hours after baseline
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.
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)
时间窗: baseline and 96 hours after baseline
A positive percent reflects an decrease; a negative percentage reflects a increase.
Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)
时间窗: baseline and 96 hours after baseline
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.
Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)
时间窗: baseline to 9 months after transplantation
Number of complications due to hepatobiliary events.
次要结局
- Effect of iNO on SICU Stay(baseline to discharge for SICU)
- Effect of iNO on Hosptial Length of Stay(from surgery through discharge from hospital)
研究者
Rakesh Patel
Professor
University of Alabama at Birmingham