Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiogenic Shock
- Sponsor
- National Research Center for Cardiac Surgery, Kazakhstan
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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. Subtask 2.2. Assessment of the normalization of the body's immune response and restoration of organ function upon implantation of the left ventricular assist device using an extracorporeal cytokine adsorber. Task 3. Studying the restoration of organ function during the implantation of the total artificial heart as an organ-replacing aid in case of heart failure. Task 3.1. Assessment of normalization of organ function restoration during implantation of the total artificial heart with the use of extracorporeal hemocorrection. Task 4. Studying the restoration of organ function during operations in conditions of the long-term cardiopulmonary bypass. Task 4.1. Assessment of the restoration of organ function during operations with long-term cardiopulmonary bypass, hypothermia, and circulatory arrest, with the use of extra corporeal hemocorrection. Task 4.2. Assessment of the restoration of organ function during operations with long-term cardiopulmonary bypass, hypothermia, and circulatory arrest using an extracorporeal cytokine adsorber. Task 5. Improvement of the method of implantation of organ-replacing technologies to reduce complications in the treatment of heart and pulmonary failure. Study design. Study type: interventional (clinical study) Set of participants: 100 participants Distribution: randomized Interventional model: parallel Masking: no Primary Goal: Treatment
Investigators
Yuriy Pya
Director for Surgery and Science
National Research Center for Cardiac Surgery, Kazakhstan
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24, 48, 72 hours
Level of serum lactate at 24, 48, 72 h
Extracorporeal life support system with pulmonary and / or heart failure
Time Frame: 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
Time Frame: 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
Time Frame: first 72 hours
Lactate level
Patients with left ventricular assist device implantation:Renal function
Time Frame: first 72 hours
creatinine level
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Secondary Outcomes
- 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)