Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
研究概览
简要总结
The purpose of the program. Formulation of new treatments for heart and pulmonary failure through using organ-replacing technologies.
Formulation of a clinical protocol and implementation of treatment methods into clinical practice heart and pulmonary failure using organ-replacing technologies.
New methods were created for rehabilitating the function of affected organs after implantation of the LVAD, a total artificial heart, an extracorporeal life-sustaining system will be of great importance, both for Kazakhstan and for states with similar problems of donor organ deficiency, will also improve the effectiveness of surgical treatment and reduce the level of complications and mortality of patients on the extracorporeal life-sustaining system and septic patients.
详细描述
Objectives of the program. Task 1. Assessment of the results of the use of extracorporeal life support systems in the treatment of pulmonary and/or heart failure.
Subtask 1.1. Assessment of the restoration of organ function during extracorporeal life support systems using extracorporeal hemocorrection.
Subtask 1.2. Assessment of the normalization of the body's immune response and restoration of organ function during extracorporeal life support systems using an extracorporeal cytokine adsorber.
Task 2. Studying the restoration of organ function during implantation of the left ventricular assist device as an organ-replacing aid in heart failure.
Subtask 2.1. Assessment of the restoration of organ function during implantation of the left ventricular assist device with the use of extracorporeal hemocorrection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on an extracorporeal life support system with heart failure:
- •Implantation of intravenous ECMO
- •Hemodynamic support with vasopressors and/or tonics;
- •Procalcitonin level ≥ 1 ng/ml;
- •Invasive hemodynamic monitoring;
- •Written informed consent.
- •Patients on an extracorporeal life support system with pulmonary failure:
- •IV ECMO implantation
- •High levels of venous and arterial CO2 (CO2> 50 mmHg),
- •Low paO2, SvO2, SpO
- •Invasive hemodynamic monitoring;
- •Written informed consent.
- •Patients with left ventricular assistive device implantation:
- •LVAD implantation
- •Biventricular heart failure IV
- •INTERMACS I-III
- •Hemodynamic support with vasopressors and/or tonics;
- •Procalcitonin level ≥ 0.1 ng/ml;
- •Invasive hemodynamic monitoring;
- •Written informed consent.
- •Patients in operations with prolonged artificial circulation, hypothermia and circulatory arrest:
- •Hemodynamic support with vasopressors and/or tonics;
- •Bypass duration> 120 minutes
- •Hypothermia ≤ 25 0С
- •Circulatory arrest
- •Procalcitonin level ≥ 1 ng/ml;
- •Invasive hemodynamic monitoring;
- •Written informed consent.
排除标准
- •Patients on an extracorporeal life support system with heart failure:
- •Age less than 18 years old
- •Terminal hepatic or renal failure just before the procedure
- •Patient's written refusal to participate in the study
- •Patients on an extracorporeal life support system with pulmonary failure:
- •Age less than 18 years old
- •Terminal hepatic or renal failure just before the procedure
- •Patient's written refusal to participate in the study
- •Patients with left ventricular assistive device implantation:
- •Age less than 18 years old
- •Acute hepatic or renal failure just before the procedure
- •Patient's written refusal to participate in the study
- •Patients in operations with prolonged artificial circulation, hypothermia and circulatory arrest:
- •Age less than 18 years old
- •Terminal hepatic or renal failure just before the procedure
- •Patient's written refusal to participate in the study
结局指标
主要结局
Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
时间窗: 24-48 hours
The level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor alpha-factor) before the start, 2 hours after the start of ECMO support, when ECMO is turned off, 24 hours after ECMO is turned off.
Patients with left ventricular assist device implantation:vasopressors and / or inotropes
时间窗: first 72 hours
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of Cytokine response
时间窗: 24-48 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin, C-reactive protein)
Extracorporeal life support system with pulmonary and / or heart failure:Difference of mean arterial pressure
时间窗: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Extracorporeal life support system with pulmonary and / or heart failure: Serum lactate
时间窗: 24, 48, 72 hours
Level of serum lactate at 24, 48, 72 h
Extracorporeal life support system with pulmonary and / or heart failure
时间窗: Time: first 72 hours
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Extracorporeal life support system with pulmonary and / or heart failure: SOFA-Score
时间窗: 24, 48, 72 hours
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Patients with left ventricular assist device implantation:Lactate level
时间窗: first 72 hours
Lactate level
Patients with left ventricular assist device implantation:Renal function
时间窗: first 72 hours
creatinine level
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP
时间窗: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Level of Serum lactate
时间窗: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Patients with left ventricular assist device implantation: Difference of Cytokine response
时间窗: 24-48 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin)
Extracorporeal life support system with pulmonary and / or heart failure: Difference of CVP
时间窗: 24, 48, 72 hours
Comparison of CVP at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: SOFA-Score
时间窗: 24, 48, 72 hours
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Extracorporeal life support system with pulmonary and / or heart failure:Days on ventilator, vasopressor and renal replacement therapy
时间窗: until day 30 post-surgery
Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of mean arterial pressure
时间窗: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
次要结局
- For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function(first 48 hours)
- Patients with left ventricular assist device implantation: Application and dosage of inotropes(first 48 hours)
- For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin(24-48 hours)
- Patients with left ventricular assist device implantation: The level of leukocytes(24-48 hours)
- Patients with left ventricular assist device implantation: The level of procalcitonin(24-48 hours)
- For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes(24-48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors(first 48 hours)
- For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)(24-48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes(24-48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin(24-48 hours)
- For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes(first 48 hours)
- Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)(24-48 hours)
- Patients with left ventricular assist device implantation: Application and dosage of vasopressors(first 48 hours)
- For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors(first 48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)(24-48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte(24-48 hours)
- Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes(first 48 hours)
研究者
Yuriy Pya
Director for Surgery and Science
National Research Center for Cardiac Surgery, Kazakhstan