Innovative Technologies for the Treatment of Pulmonary and Heart Failure

Sepsis Clinical Trial

Official title:

Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05090930
• Other study ID #: version01
• Secondary ID: BR10965200
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: October 2021
• Source: National Research Center for Cardiac Surgery, Kazakhstan
• Contact: Yuri Pya, PhD, MD
• Phone: +77172272090
• Email: rp.nrcsc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Cardiac Arrest With Successful Resuscitation
• Cardiogenic Shock
• Decompensated Heart Failure
• Heart Failure
• Multiple Organ Failure
• Pulmonary Failure
• Sepsis
• Shock, Cardiogenic
• Ventricular Arrythmia

Intervention

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

Locations

Country	Name	City	State
Kazakhstan	National Research Center For Cardiac Surgery	Astana

Sponsors (2)

Lead Sponsor	Collaborator
National Research Center for Cardiac Surgery, Kazakhstan	Ministry of Education and Science, Republic of Kazakhstan

Country where clinical trial is conducted

Kazakhstan, 

References & Publications (41)

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* Note: There are 41 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	Length of stay in the intensive care unit	first 48 hours
Other	Length of hospital stay	Length of hospital stay	up to 1 month
Other	30 day survival rate.	30 day survival rate.	30 day
Primary	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
Primary	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
Primary	Extracorporeal life support system with pulmonary and / or heart failure	Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)	Time: first 72 hours
Primary	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
Primary	Patients with left ventricular assist device implantation:vasopressors and / or inotropes	Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)	first 72 hours
Primary	Patients with left ventricular assist device implantation:Renal function	creatinine level	first 72 hours
Primary	Patients with left ventricular assist device implantation:Lactate level	Lactate level	first 72 hours
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)	The level of C-reactive protein (CRP) before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.	24-48 hours
Secondary	Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte	Level of leukocyte cells in the bloodstream at 24, 48 hours	24-48 hours
Secondary	Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors	Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery	first 48 hours
Secondary	Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)	The level of C-reactive protein (CRP) before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation	24-48 hours
Secondary	Patients with left ventricular assist device implantation: Application and dosage of vasopressors	Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery	first 48 hours
Secondary	For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)	The level of C-reactive protein (CRP) before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.	24-48 hours
Secondary	For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function	Leukocyte function: heterogeneity of the population of leukocyte cells in the bloodstream	first 48 hours
Secondary	For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors	Incidence of application and level of dosage of vasopressors on days 2 and 3 after surgery	first 48 hours
Secondary	Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes	The level of leukocytes before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation	24-48 hours
Secondary	Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin	The level of procalcitonin before the start of ECMO, 2 hours after the implantation of ECMO, during ECMO, 24 hours after ECMO explantation.	24-48 hours
Secondary	Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes	Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery	first 48 hours
Secondary	Patients with left ventricular assist device implantation: The level of leukocytes	The level of leukocytes before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation	24-48 hours
Secondary	Patients with left ventricular assist device implantation: The level of procalcitonin	The level of procalcitonin before the start of the operation, 2 hours after the start of the operation, when the operation is turned off, 24 hours after the shutdown of the operation	24-48 hours
Secondary	Patients with left ventricular assist device implantation: Application and dosage of inotropes	Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery	first 48 hours
Secondary	For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes	The level of leukocytes before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.	24-48 hours
Secondary	For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin	The level of procalcitonin before the cardiopulmonary bypass 2 hours after the cardiopulmonary bypass, when the cardiopulmonary bypass is turned off, 24 hours after the cardiopulmonary bypass.	24-48 hours
Secondary	For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes	Incidence of application and level of dosage of inotropes on days 2 and 3 after surgery	first 48 hours