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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, which is based on the removal of cytokines from whole blood by sorption on a special hemoadsorbent due to the peculiarities of its porous structure and inner surface, which is indicated in conditions where cytokine levels are extremely elevated
CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber is a biocompatible polymer with high adsorption capacity, which is indicated in conditions where cytokine levels are extremely elevated
National Research Center For Cardiac Surgery
Astana, Kazakhstan
RECRUITINGExtracorporeal life support system with pulmonary and / or heart failure: Cytokine response
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.
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure: SOFA-Score
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Time frame: Time: first 72 hours
Patients with left ventricular assist device implantation: Difference of Cytokine response
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin)
Time frame: 24-48 hours
Patients with left ventricular assist device implantation:vasopressors and / or inotropes
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Time frame: first 72 hours
Patients with left ventricular assist device implantation:Renal function
creatinine level
Time frame: first 72 hours
Patients with left ventricular assist device implantation:Lactate level
Lactate level
Time frame: first 72 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of Cytokine response
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin, C-reactive protein)
Time frame: 24-48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: SOFA-Score
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure:Difference of mean arterial pressure
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure: Difference of CVP
Comparison of CVP at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure: Serum lactate
Level of serum lactate at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure:Days on ventilator, vasopressor and renal replacement therapy
Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
Time frame: until day 30 post-surgery
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of mean arterial pressure
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Time frame: 24, 48, 72 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Time frame: 24, 48, 72 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Level of Serum lactate
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Time frame: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)
The level of C-reactive protein (CRP) before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte
Level of leukocyte cells in the bloodstream at 24, 48 hours
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors
Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery
Time frame: first 48 hours
Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)
The level of C-reactive protein (CRP) before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: Application and dosage of vasopressors
Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery
Time frame: first 48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)
The level of C-reactive protein (CRP) before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.
Time frame: 24-48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Leukocyte function: heterogeneity of the population of leukocyte cells in the bloodstream
Time frame: first 48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors
Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery
Time frame: first 48 hours
Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes
The level of leukocytes before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin
The level of procalcitonin before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes
Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery
Time frame: first 48 hours
Patients with left ventricular assist device implantation: The level of leukocytes
The level of leukocytes before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: The level of procalcitonin
The level of procalcitonin before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: Application and dosage of inotropes
Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery
Time frame: first 48 hours
For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes
The level of leukocytes before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.
Time frame: 24-48 hours
For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin
The level of procalcitonin before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.
Time frame: 24-48 hours
For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes
Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery
Time frame: first 48 hours