Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
2014年11月5日 更新者:Rakesh Patel、University of Alabama at Birmingham
Effects of Inhaled Nitric Oxide on Ischemia-Reperfusion Injury in Human Liver During Transplantation
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
80
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35294
- University of Alabama at Birmingham
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Washington
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Seattle、Washington、美国、98195-6540
- University of Washington
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
19年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients > 19 yr of age scheduled to undergo liver transplantation.
Exclusion Criteria:
- Patients < 19 yr of age
- Patients undergoing re-transplantation or dual organ transplantation
- Patients with underlying pulmonary complications
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1. Experimental
iNO administration
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inhaled 80ppm for duration of surgery.
其他名称:
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安慰剂比较:2. Placebo
Placebo (nitrogen)
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inhaled
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels)
大体时间:baseline and 96 hours after baseline
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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).
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baseline and 96 hours after baseline
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Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels)
大体时间:baseline and 96 hours after baseline
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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).
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baseline and 96 hours after baseline
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Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels)
大体时间:baseline and 96 hours after baseline
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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.
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baseline and 96 hours after baseline
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Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT))
大体时间:baseline and 96 hours after baseline
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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.
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baseline and 96 hours after baseline
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Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels)
大体时间:baseline and 96 hours after baseline
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A positive percent reflects an decrease; a negative percentage reflects a increase.
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baseline and 96 hours after baseline
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Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications)
大体时间:baseline to 9 months after transplantation
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Number of complications due to hepatobiliary events.
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baseline to 9 months after transplantation
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Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery
大体时间:baseline to 9 months post surgery
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Number of any complication reported by subjects at 9 months after surgery
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baseline to 9 months post surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Effect of iNO on Hosptial Length of Stay
大体时间:from surgery through discharge from hospital
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number of days subject in hospital after surgery until discharge
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from surgery through discharge from hospital
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Effect of iNO on SICU Stay
大体时间:baseline to discharge for SICU
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Number of minutes after surgery subject remained in SICU
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baseline to discharge for SICU
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Rakesh P Patel, PhD、University of Alabama at Birmingham
- 首席研究员:Keith A Jones, MD、University of Alabama at Birmingham
- 首席研究员:Devin E Eckhoff, MD、University of Alabama at Birmingham
- 研究主任:John S Bynon, MD、University of Alabama at Birmingham
- 研究主任:Blair Smith, MD、University of Alabama at Birmingham
- 学习椅:Clark Cross, MD、University of Alabama at Birmingham
- 研究主任:Luc Frenette, MD、University of Alabama at Birmingham
- 首席研究员:John D Lang, MD、University of Washington
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年4月1日
初级完成 (实际的)
2009年3月1日
研究完成 (实际的)
2012年10月1日
研究注册日期
首次提交
2007年12月20日
首先提交符合 QC 标准的
2007年12月27日
首次发布 (估计)
2007年12月28日
研究记录更新
最后更新发布 (估计)
2014年11月6日
上次提交的符合 QC 标准的更新
2014年11月5日
最后验证
2014年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
inhaled nitric oxide的临床试验
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Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI)完全的滤泡性淋巴瘤 | 骨髓性白血病 | 真性红细胞增多症 | 霍奇金淋巴瘤 | 骨髓纤维化 | 慢性粒单核细胞白血病 | 复发性成人急性髓性白血病 | 慢性淋巴细胞白血病 | 继发性急性髓性白血病 | 非霍奇金淋巴瘤 | 骨髓增生异常综合症 | 浆细胞骨髓瘤 | 难治性急性髓性白血病 | 复发性儿童急性髓性白血病 | 再生障碍性贫血 | 治疗相关的急性髓性白血病 | 慢性粒细胞白血病,BCR-ABL1 阳性 | 具有 FLT3/ITD 突变的急性髓性白血病 | 具有基因突变的急性髓性白血病 | 伴有 Inv(3) 的急性髓性白血病 (q21.3;q26.2); GATA2、MECOM | 具有 t(6;9) (p23;q34.1) 的急性髓性白血病; DEK-NUP214美国
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Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)招聘中弥漫性大 B 细胞淋巴瘤 | 高级别 B 细胞淋巴瘤 | 双表达淋巴瘤 | 具有 MYC 和 BCL2 或 BCL6 重排的高级别 B 细胞淋巴瘤 | 具有 MYC、BCL2 和 BCL6 重排的高级别 B 细胞淋巴瘤美国