Innovative Technologies for the Treatment of Pulmonary and Heart Failure

National Research Center for Cardiac Surgery, Kazakhstan

Status: Unknown

Conditions: Multiple Organ Failure; Decompensated Heart Failure; Pulmonary Failure; Acute Heart Failure; Ventricular Arrythmia; Cardiac Arrest With Successful Resuscitation; Cardiogenic Shock; Sepsis

Treatments: Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection; Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

Study type: Interventional

Funder types: Other

Identifiers

NCT05090930

version01

BR10965200 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 0С

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 8 patient groups

Intervention team (1/1 group)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure... (10 patients)

Treatment:

Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

Intervention team (1/2 group)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for pulmonary failure (10 patients).

Treatment:

Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

Intervention team (1/3 group)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in patients before/during the implantation of a left ventricular accessory (5 patients).

Treatment:

Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

Intervention team (1/4 group)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in patients during operations with prolonged artificial circulation, hypothermia, and circulatory arrest. (25 patients).

Treatment:

Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection

Intervention team (2/1 groups)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure. (10 patients)

Treatment:

Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

Intervention team (2/2 groups)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for pulmonary failure. (10 patients)

Treatment:

Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

Intervention team (2/3 groups)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in patients before/during the implantation of a left ventricular accessory (5 patients)

Treatment:

Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber

Intervention team (2/4 groups)

Active Comparator group

Description:

An extracorporeal hemoperfusion device will be installed in patients during operations with prolonged artificial circulation, hypothermia, and circulatory arrest. (25 patients)

Treatment:

Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber