Removal of Cytokines in Patients Undergoing Cardiac Surgery With CPB (The REMOTE Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cytokine levels following CPB
研究概览
简要总结
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
Use of cytokine adsorption within the extracorporeal circuit during CBP can affect the circulating cytokine levels during and after CPB and lead to a diminished inflammatory response, acute phase reaction as well as reduction of organ failure.
详细描述
In a lot of cases during cardiac surgery cardiopulmonary bypass initiates SIRS due to release of cytokines during immunological response.
They are induced by different types of inductors ( intrinsic and extrinsic). High levels of inflammation markers like TNF-a, IL 6 and IL 10 as well as TGF-ß are detectable after 2 hours of surgery.
Beside the inflammation acute phase parameters like fibrinogen, ferritin are increased. These changes lead to rheology impairments.
These strong reactions lead to dysfunction of different organs possibly culminating in a multi organ failure.
There is a correlation between amounts of cytokines and mortality. Often AKI occurs after CPB with a rate of about 30%. Dysfunctions of organ function are often connected with increased mortality, prolonged mechanical ventilation , septic complications, increased catecholamine dosages and prolonged length of ICU stay.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery with CPB
- •Signed informed consent
- •CPB time > 75 min.
- •Comorbidities:
- •diabetes mellitus
- •CHF, NYHA class 1 and 2
- •liver dysfunction (1, 2)
- •kidney dysfunction (1, 2)
- •hypertension
- •arteriosclerosis
排除标准
- •Age < 65 years
- •Declined informed consent
- •Planed temperature < 32 C
- •Emergency surgery
- •Preexisting renal replacement therapy
- •Preexisting kidney transplantation
- •Administration of immunosuppressants like steroids
- •AIDS with CD 4 < 200/
- •Participation in other trials
结局指标
主要结局
Cytokine levels following CPB
时间窗: 72 hours
Evaluation of cytokine adsorber effect on cytokine levels intra- and post
次要结局
- Level of haptoglobin(72 hours)
- Intra- and postoperative catecholamine dosages(until ICU discharge, expected average 4 days)
- Level of transferrin(72 hours)
- postoperative renal failure necessitating RRT(until ICU discharge, expected average 4 days)
- Level of ferritin(72 hours)
- Length of ICU stay(until discharge from ICU, expected average 4 days)
- Length of hospital stay(up to hospital discharge, expected average 14 days)
研究者
PD Dr. med. Giuseppe Santarpino
PD, Dr. med
Klinikum Nürnberg