Innovative Technologies for the Treatment of Pulmonary and Heart Failure

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    100
  • sponsor
    National Research Center for Cardiac Surgery, Kazakhstan
Updated on 31 October 2021
procalcitonin
cytokines
pao2
vasoconstrictors

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.

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

Details
Condition Pulmonary Failure, failure pulmonary, Sepsis and Septicemia, multi-organ failure, multiple organ dysfunction syndrome, Cardiogenic shock, Multiple Organ Failure, multiorgan failure, Ventricular Arrythmia, systemic infection, sepsis syndrome, systemic infections, Septicemia, Decompensated Heart Failure, Cardiac Arrest With Successful Resuscitation, mods, Acute Heart Failure, sepsis
Treatment HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber
Clinical Study IdentifierNCT05090930
SponsorNational Research Center for Cardiac Surgery, Kazakhstan
Last Modified on31 October 2021

Eligibility

Yes No Not Sure

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, SpO2
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 0
Circulatory arrest
Procalcitonin level 1 ng/ml
Invasive hemodynamic monitoring
Written informed consent

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
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
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