Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
NCT ID: NCT05042622
Last Updated: 2021-09-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
90 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-01-01
Study Completion Date
2023-12-31
Brief Summary
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The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
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Detailed Description
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The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients.
Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients.
Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge.
In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure.
New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality.
Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery.
Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into 3 groups:
* Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
* Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
* Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO subgroup - E, septic patients - subgroup F.
The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented.
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables.
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients.
Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients.
Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge.
In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure.
New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality.
Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery.
Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into 3 groups:
* Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
* Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
* Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO subgroup - E, septic patients - subgroup F.
The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented.
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables.
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
Conditions
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Acute Respiratory Distress Syndrome
Septic Shock
Sepsis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Cytokine adsorber patients on ECMO
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
Group Type
EXPERIMENTAL
Cytokine adsorber filter
Intervention Type
DEVICE
• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
Cytokine adsorber patients with sepsis
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
Group Type
EXPERIMENTAL
Cytokine adsorber filter
Intervention Type
DEVICE
• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
Extracorporeal hemoperfusion cartridge patients on ECMO
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
Group Type
EXPERIMENTAL
Extracorporeal hemoperfusion cartridge
Intervention Type
DEVICE
• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
Extracorporeal hemoperfusion cartridge patients with sepsis
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
Group Type
EXPERIMENTAL
Extracorporeal hemoperfusion cartridge
Intervention Type
DEVICE
• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
Control (subgroups)1
No filter will be installed into the ECMO in this study group (15 patients)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Control (subgroups) 2
No filter will be installed into the patient with sepsis (15 patients)
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Cytokine adsorber filter
• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
Intervention Type
DEVICE
Extracorporeal hemoperfusion cartridge
• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
Intervention Type
DEVICE
Eligibility Criteria
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Inclusion Criteria
\-
ICU patients with ECMO:
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 1 ng/ml
* Invasive hemodynamic monitoring
* Written informed content
ICU patients with the septic shock of medical origin:
* Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 1 ng/ml
* Invasive hemodynamic monitoring
* Written informed content
ICU patients with ECMO:
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 1 ng/ml
* Invasive hemodynamic monitoring
* Written informed content
ICU patients with the septic shock of medical origin:
* Signs of hypoperfusion: serum lactate \>2 mmol/L, low central venous oxygen saturation (ScvO2) (\<70%) or high ScvO2 (\>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 \>6 mm Hg)
* Hemodynamic support with vasopressors
* Procalcitonin level ≥ 1 ng/ml
* Invasive hemodynamic monitoring
* Written informed content
Exclusion Criteria
* ICU patients with ECMO:
* age \< 18 years
* acute liver or kidney failure straight before transplantation
* the patient declines to participate in the study
ICU patients with the septic shock of medical origin:
* Patients under 18 years
* Pregnancy (bHCG test positivity)
* Surgical intervention in context with the septic insult New York Heart Association IV heart failure
* Acute coronary syndrome
* Acute hematological malignancies
* Immunosuppression, systemic steroid therapy (\>10mg prednisolone/day)
* Human immunodeficiency virus infection (HIV) and active AIDS
* Patients with donated organs
* Thrombocytopenia (\<20.000/ml)
* More than 10%-of body surface area with third-degree burn
* age \< 18 years
* acute liver or kidney failure straight before transplantation
* the patient declines to participate in the study
ICU patients with the septic shock of medical origin:
* Patients under 18 years
* Pregnancy (bHCG test positivity)
* Surgical intervention in context with the septic insult New York Heart Association IV heart failure
* Acute coronary syndrome
* Acute hematological malignancies
* Immunosuppression, systemic steroid therapy (\>10mg prednisolone/day)
* Human immunodeficiency virus infection (HIV) and active AIDS
* Patients with donated organs
* Thrombocytopenia (\<20.000/ml)
* More than 10%-of body surface area with third-degree burn
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Ministry of Education and Science, Republic of Kazakhstan
OTHER_GOV
Sponsor Role
collaborator
National Research Center for Cardiac Surgery, Kazakhstan
OTHER
Sponsor Role
lead
Responsible Party
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Timur Lesbekov
Head of the Department of Cardiac Surgery
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Timur Lesbekov, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
National research Center for Cardiac Surgery JSC
Locations
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National Research Center for Cardiac Surgery
Astana, , Kazakhstan
Site Status
RECRUITING
Countries
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Kazakhstan
Central Contacts
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Facility Contacts
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References
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Venet F, Lukaszewicz AC, Payen D, Hotchkiss R, Monneret G. Monitoring the immune response in sepsis: a rational approach to administration of immunoadjuvant therapies. Curr Opin Immunol. 2013 Aug;25(4):477-83. doi: 10.1016/j.coi.2013.05.006. Epub 2013 May 28.
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Hunt SA. Taking heart--cardiac transplantation past, present, and future. N Engl J Med. 2006 Jul 20;355(3):231-5. doi: 10.1056/NEJMp068048. No abstract available.
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Hunt SA, Haddad F. The changing face of heart transplantation. J Am Coll Cardiol. 2008 Aug 19;52(8):587-98. doi: 10.1016/j.jacc.2008.05.020.
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Lund LH, Edwards LB, Kucheryavaya AY, Benden C, Christie JD, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Meiser B, Yusen RD, Stehlik J; International Society of Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first official adult heart transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):996-1008. doi: 10.1016/j.healun.2014.08.003. Epub 2014 Aug 14. No abstract available.
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Banner NR, Thomas HL, Curnow E, Hussey JC, Rogers CA, Bonser RS; Steering Group of the United Kingdom Cardiothoracic Transplant Audit. The importance of cold and warm cardiac ischemia for survival after heart transplantation. Transplantation. 2008 Aug 27;86(4):542-7. doi: 10.1097/TP.0b013e31818149b9.
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RESULT
Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T; Society for Cardiovascular Angiography and Interventions (SCAI); Heart Failure Society of America (HFSA); Society for Thoracic Surgeons (STS); American Heart Association (AHA); American College of Cardiology (ACC). 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention). J Card Fail. 2015 Jun;21(6):499-518. doi: 10.1016/j.cardfail.2015.03.002.
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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version 1.1
Identifier Type: -
Identifier Source: org_study_id
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