Innovative Technologies for the Treatment of Pulmonary and Heart Failure

NCT05090930 | Unknown

• 2 other identifiers: version01BR10965200
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (16)

• Extracorporeal 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.

  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)

  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: 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)

  24-48 hours

• Patients with left ventricular assist device implantation:vasopressors and / or inotropes

  Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)

  first 72 hours

• Patients with left ventricular assist device implantation:Renal function

  creatinine level

  first 72 hours

• Patients with left ventricular assist device implantation:Lactate level

  Lactate level

  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)

  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)

  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)

  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)

  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

  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

  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)

  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)

  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)

  24, 48, 72 hours

Secondary Outcomes (17)

• Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)

  24-48 hours

• Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte

  24-48 hours

• Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors

  first 48 hours

• Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)

  24-48 hours

• Patients with left ventricular assist device implantation: Application and dosage of vasopressors

  first 48 hours

Other Outcomes (3)

• Length of stay

  first 48 hours

• Length of hospital stay

  up to 1 month

• 30 day survival rate.

  30 day

Study Arms (8)

Intervention team (1/1 group)

ACTIVE COMPARATOR

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

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

Intervention team (1/2 group)

ACTIVE COMPARATOR

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

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

Intervention team (1/3 group)

ACTIVE COMPARATOR

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

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

Intervention team (1/4 group)

ACTIVE COMPARATOR

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

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

Intervention team (2/1 groups)

ACTIVE COMPARATOR

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

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

Intervention team (2/2 groups)

ACTIVE COMPARATOR

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

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

Intervention team (2/3 groups)

ACTIVE COMPARATOR

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

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

Intervention team (2/4 groups)

ACTIVE COMPARATOR

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

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

Interventions

HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection DEVICE

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

Intervention team (1/1 group); Intervention team (1/2 group); Intervention team (1/3 group); Intervention team (1/4 group)

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

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

Intervention team (2/1 groups); Intervention team (2/2 groups); Intervention team (2/3 groups); Intervention team (2/4 groups)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Center for Cardiac Surgery, Kazakhstan: lead
• Ministry of Education and Science, Republic of Kazakhstan: collaborator

Study Sites (1)

National Research Center For Cardiac Surgery

Astana, 010000, Kazakhstan

RECRUITING

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MeSH Terms

Conditions

Shock, Cardiogenic; Sepsis; Multiple Organ Failure

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Infections; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Yuri Pya, PhD, MD

  National research Center for Cardiac Surgery JSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuri Pya, PhD, MD

CONTACT

+77172272090; rp.nrcsc@gmail.com

Timur Lesbekov, MD

CONTACT

+77172703100; lesbekovt@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director for Surgery and Science

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 25, 2021
• Study Start: January 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: from October 2021 year and will become available till December 2023 year.
• Access Criteria: The resulting patient data will be strictly confidential with ensuring privacy through strictly limited access to data, de-identification of data and destruction after the end of the study.

Locations

KA (1)