Clinical trial NCT05090930: Innovative Technologies for the Treatment of Pulmonary and Heart Failure
Official title: Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiogenic Shock
Ventricular Arrythmia
Cardiac Arrest With Successful Resuscitation
Sepsis
Multiple Organ Failure
Pulmonary Failure
Decompensated Heart Failure
Acute Heart Failure
Keywords: Anesthesiology
Cardiothoracic surgery
Nephrology
Perfusion
Efferentology
Lead sponsor: National Research Center for Cardiac Surgery, Kazakhstan
Sponsor class: OTHER
Collaborators: name: Ministry of Education and Science, Republic of Kazakhstan
First posted: 2021-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention team # 1 using an extracorporeal hemoperfusion device Jafron (Zhuhai Jafron Biomedical, China) (50 patients) in subgroups: A (n = 10) - patients on extracorporeal life support systems with heart failure; B (n = 10) - patients on extracorporeal life support systems with pulmonary failure; C (n = 5) - patients with implantation of a left ventricular accessory device; D (n = 25) - during operations with prolonged artificial circulation, hypothermia and circulatory arrest.

Intervention team # 2 using extracorporeal cytokine, CytoSorb (CytoSorbents Corporation, Monmouth Junction, NJ, USA) (50 patients) in subgroups: A (n = 10) - patients on extracorporeal life support systems in heart failure; B (n = 10) - patients on extracorporeal life support systems with pulmonary failure; C (n = 5) - patients with implantation of a left ventricular accessory device; D (n = 25) - during operations with prolonged artificial circulation, hypothermia and circulatory arrest.
Primary purpose: TREATMENT

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

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, 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

Primary outcomes:
measure: Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
timeFrame: 24-48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure: SOFA-Score
timeFrame: 24, 48, 72 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure
timeFrame: Time: first 72 hours
measure: Patients with left ventricular assist device implantation: Difference of Cytokine response
timeFrame: 24-48 hours
measure: Patients with left ventricular assist device implantation:vasopressors and / or inotropes
timeFrame: first 72 hours
measure: Patients with left ventricular assist device implantation:Renal function
timeFrame: first 72 hours
measure: Patients with left ventricular assist device implantation:Lactate level
timeFrame: first 72 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of Cytokine response
timeFrame: 24-48 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: SOFA-Score
timeFrame: 24, 48, 72 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:Difference of mean arterial pressure
timeFrame: 24, 48, 72 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure: Difference of CVP
timeFrame: 24, 48, 72 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure: Serum lactate
timeFrame: 24, 48, 72 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:Days on ventilator, vasopressor and renal replacement therapy
timeFrame: until day 30 post-surgery
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of mean arterial pressure
timeFrame: 24, 48, 72 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP
timeFrame: 24, 48, 72 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Level of Serum lactate
timeFrame: 24, 48, 72 hours
Secondary outcomes:
measure: Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)
timeFrame: 24-48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte
timeFrame: 24-48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors
timeFrame: first 48 hours
measure: Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)
timeFrame: 24-48 hours
measure: Patients with left ventricular assist device implantation: Application and dosage of vasopressors
timeFrame: first 48 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)
timeFrame: 24-48 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function
timeFrame: first 48 hours
measure: For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors
timeFrame: first 48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes
timeFrame: 24-48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin
timeFrame: 24-48 hours
measure: Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes
timeFrame: first 48 hours
measure: Patients with left ventricular assist device implantation: The level of leukocytes
timeFrame: 24-48 hours
measure: Patients with left ventricular assist device implantation: The level of procalcitonin
timeFrame: 24-48 hours
measure: Patients with left ventricular assist device implantation: Application and dosage of inotropes
timeFrame: first 48 hours
measure: For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes
timeFrame: 24-48 hours
measure: For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin
timeFrame: 24-48 hours
measure: For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes
timeFrame: first 48 hours
Other outcomes:
measure: Length of stay
timeFrame: first 48 hours
measure: Length of hospital stay
timeFrame: up to 1 month
measure: 30 day survival rate.
timeFrame: 30 day
Locations:
city: Astana
country: Kazakhstan
facility: National Research Center For Cardiac Surgery
Study officials:
affiliation: National research Center for Cardiac Surgery JSC
name: Yuri Pya, PhD, MD
role: PRINCIPAL_INVESTIGATOR
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