The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage. The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure. Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure. Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage. 2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure. 2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure. Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure. Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber. Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge. Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis. Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients. Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients. Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge. In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure. New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality. Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery. Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent. The participants will be randomized into 3 groups: * Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B. * Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D. * Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO subgroup - E, septic patients - subgroup F. The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented. The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables. Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
National Research Center for Cardiac Surgery
Astana, Kazakhstan
RECRUITINGDifference of Cytokine response - ECMO patients
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) before initiation of ECMO, 2 hours after initiation ECMO support, at explantation of ECMO support, 6-12-24 hours after explantation of ECMO support.
Time frame: 6-24 hours
Difference of Cytokine response - Patients with septic shock
Level of procalcitonin, Level of C-reactive protein, Level of interleukin-1, Level of interleukin-6, Level of interleukin-8, Level of interleukin-10, Level of Tumor Necrosis Factor- αinterleukin-8, interleukin-10, Tumor Necrosis Factor- α at 24, 48 hours.
Time frame: 24-48 hours of septic shock
Inflammatory reaction - Patients with septic shock
Level of C reactive protein (CRP), white blood cells and procalcitonin immediately after induction of anesthesia, before initiation of adsorber, 2 hours after initiation of adsorber, at termination of adsorber, 6-12-24 hours after wean of adsorber.
Time frame: 6-24 hours
Ventilator free days (VFD) - ECMO patients
ventilator days. VFD=0, if the patient dies in the first 30 days after randomization
Time frame: 30 days
Time to extubation from ventilation and explantation from ECMO - ECMO patients
Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO.
Time frame: 30 days
Difference of d-dimers - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Difference of Serum lactate - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
SOFA-Score - ECMO patients
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
serious adverse device effects - ECMO patients
serious complications or malfunctions related to the CytoSorb device
Time frame: 30 days
adverse event of special interest: air in the ECMO system - ECMO patients
unintended air in the ECMO system during operation of the device
Time frame: 30 days
adverse event of special interest: blood-clotting in the ECMO system
unintended blood-clotting in the ECMO system during operation of the device
Time frame: 30 days
adverse event of special interest: bleeding complications - ECMO patients
major bleeding events
Time frame: 30 days
Difference of serum interleukin-6 level - Patients with septic shock
Comparison to enrollment or between 3 groups at 48, 72 h
Time frame: 48, 72 hours
Difference of serum interleukin-1β level - Patients with septic shock
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Difference of serum interleukin-10 level - Patients with septic shock
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Difference of serum procalcitonin level - Patients with septic shock
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
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