Cytokine Adsorption in Lung Transplantation: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Oxygenation at 48 hours
研究概览
简要总结
Lung transplantation (LTx) remains the gold standard for treating patients with irreversible end-stage pulmonary disease. Of the major organs transplanted, survival in LTx recipients remains the lowest (mean 5 years). Despite improvements, primary graft dysfunction (PGD), as defined by respiratory insufficiency and edema up to 72 hours post LTx, remains the leading cause of early mortality and contributes to the development of chronic lung allograft dysfunction (CLAD) which is the leading cause of late mortality (2). PGD develops within the first 72 hours after LTx. The development of CLAD increases quickly with cumulative incidence of 40-80 % within the first 3-5 years. There is a general lack of efficient treatments for PGD and CLAD. Prevention of PGD is therefore of crucial importance and has a direct impact on survival.
The present study is a randomized controlled pilot study which aims to compare patients undergoing LTx with and without the utilization of cytokine adsorption.
详细描述
Early intolerance to the newly transplanted lung starts at the time of transplantation and results in PGD driven by an intense inflammatory response. Cytokines play a critical role as signaling molecules that initiate, amplify, and maintain inflammatory responses both locally and systemically. The use of cytokine filtration devices to target middle- and low-molecular weight molecules has been shown to reduce levels of a diverse number of cytokines. These results have been demonstrated in the in vitro reduction of pathogen-associated molecular pattern molecules (PAMPS) and damage associated molecular patterns (DAMPS) as well as in in vivo studies involving orthotopic heart transplantation and kidney transplantation. Cytokine adsorption has been used successfully in clinical applications to both heart and kidney transplantation.
The present study is a randomized controlled pilot study which aims to collect preliminary data on the efficacy of a medical device through the comparison of patients undergoing LTx with and without cytokine adsorption.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Double lung transplantation
- •Single organ failure
排除标准
- •Re-transplantation
- •Drug abuse
- •Kidney failure
- •Liver failure
- •Diabetes mellitus
结局指标
主要结局
Oxygenation at 48 hours
时间窗: 48 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 48 hours
Oxygenation at 24 hours
时间窗: 24 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 24 hours
Oxygenation at 72 hours
时间窗: 72 hours after lung transplantation
Oxygenation expressed as the PaO2/FiO2 ratio at 72 hours
次要结局
- Diffusion capacity of the lungs (DLCO)(3 months after transplantation)
- Primary Graft dysfunction after 48 hours(48 hours after lungtransplantation)
- Rates of dialysis as a measure of kidney function(First 3 months)
- Volume blood loss(First 24 hours)
- Urinary output as a measure of kidney function(First 3 months)
- Urea levels as a measure of kidney function(First 3 months)
- Primary Graft dysfunction after 24 hours(24 hours after lung transplantation)
- Primary Graft dysfunction after 72 hours(72 hours after lungtransplantation)
- Creatinine levels and clearance as a measure of kidney function(First 3 months)
研究者
Sandra Lindstedt
Professor
Lund University Hospital