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| ID | Type | Description | Link |
|---|---|---|---|
| BR10965200 | Other Grant/Funding Number | Ministry of Education and Science RK |
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| Name | Class |
|---|---|
| Ministry of Education and Science, Republic of Kazakhstan | OTHER_GOV |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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). |
|
| 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). |
|
| 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). |
|
| Intervention team (2/1 groups) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Length of stay in the intensive care unit | first 48 hours |
| Length of hospital stay | Length of hospital stay | up to 1 month |
Inclusion Criteria:
Patients on an extracorporeal life support system with heart failure:
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:
Patients on an extracorporeal life support system with pulmonary failure:
Patients with left ventricular assistive device implantation:
Patients in operations with prolonged artificial circulation, hypothermia and circulatory arrest:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuri Pya, PhD, MD | Contact | +77172272090 | rp.nrcsc@gmail.com | |
| Timur Lesbekov, MD | Contact | +77172703100 | lesbekovt@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Yuri Pya, PhD, MD | National research Center for Cardiac Surgery JSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center For Cardiac Surgery | Recruiting | Astana | 010000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20413034 | Result | Starling RC. Improved quantity and quality of life: a winning combination to treat advanced heart failure. J Am Coll Cardiol. 2010 Apr 27;55(17):1835-6. doi: 10.1016/j.jacc.2010.03.010. No abstract available. | |
| 22891167 | Result | Maciver J, Ross HJ. Quality of life and left ventricular assist device support. Circulation. 2012 Aug 14;126(7):866-74. doi: 10.1161/CIRCULATIONAHA.111.040279. No abstract available. |
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Yes: There is a plan to make IPD and related data dictionaries available.
from October 2021 year and will become available till December 2023 year.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2021 |
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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.
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An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure. (10 patients) |
|
| 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) |
|
| 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) |
|
| 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) |
|
|
| 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 |
|
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 |
Level of leukocyte cells in the bloodstream at 24, 48 hours |
| 24-48 hours |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 30 day survival rate. | 30 day survival rate. | 30 day |
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| 22751621 | Result | Namas RA, Namas R, Lagoa C, Barclay D, Mi Q, Zamora R, Peng Z, Wen X, Fedorchak MV, Valenti IE, Federspiel WJ, Kellum JA, Vodovotz Y. Hemoadsorption reprograms inflammation in experimental gram-negative septic peritonitis: insights from in vivo and in silico studies. Mol Med. 2012 Dec 20;18(1):1366-74. doi: 10.2119/molmed.2012.00106. |
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| 28757818 | Result | Trasy D, Molnar Z. Procalcitonin - Assisted Antibiotic Strategy in Sepsis. EJIFCC. 2017 May 1;28(2):104-113. eCollection 2017 May. |
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| 29386200 | Result | Benjamin EJ, Virani SS, Callaway CW, Chamberlain AM, Chang AR, Cheng S, Chiuve SE, Cushman M, Delling FN, Deo R, de Ferranti SD, Ferguson JF, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Lutsey PL, Mackey JS, Matchar DB, Matsushita K, Mussolino ME, Nasir K, O'Flaherty M, Palaniappan LP, Pandey A, Pandey DK, Reeves MJ, Ritchey MD, Rodriguez CJ, Roth GA, Rosamond WD, Sampson UKA, Satou GM, Shah SH, Spartano NL, Tirschwell DL, Tsao CW, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2018 Update: A Report From the American Heart Association. Circulation. 2018 Mar 20;137(12):e67-e492. doi: 10.1161/CIR.0000000000000558. Epub 2018 Jan 31. No abstract available. |
| 23519193 | Result | Rodriguez LE, Suarez EE, Loebe M, Bruckner BA. Ventricular assist devices (VAD) therapy: new technology, new hope? Methodist Debakey Cardiovasc J. 2013 Jan-Mar;9(1):32-7. doi: 10.14797/mdcj-9-1-32. |
| 17638928 | Result | Lietz K, Long JW, Kfoury AG, Slaughter MS, Silver MA, Milano CA, Rogers JG, Naka Y, Mancini D, Miller LW. Outcomes of left ventricular assist device implantation as destination therapy in the post-REMATCH era: implications for patient selection. Circulation. 2007 Jul 31;116(5):497-505. doi: 10.1161/CIRCULATIONAHA.107.691972. Epub 2007 Jul 16. |
| 23352391 | Result | Feldman D, Pamboukian SV, Teuteberg JJ, Birks E, Lietz K, Moore SA, Morgan JA, Arabia F, Bauman ME, Buchholz HW, Deng M, Dickstein ML, El-Banayosy A, Elliot T, Goldstein DJ, Grady KL, Jones K, Hryniewicz K, John R, Kaan A, Kusne S, Loebe M, Massicotte MP, Moazami N, Mohacsi P, Mooney M, Nelson T, Pagani F, Perry W, Potapov EV, Eduardo Rame J, Russell SD, Sorensen EN, Sun B, Strueber M, Mangi AA, Petty MG, Rogers J; International Society for Heart and Lung Transplantation. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013 Feb;32(2):157-87. doi: 10.1016/j.healun.2012.09.013. No abstract available. |
| 23888228 | Result | Hetzer R, Delmo Walter EM. Trends and outcomes in heart transplantation: the Berlin experience. HSR Proc Intensive Care Cardiovasc Anesth. 2013;5(2):76-80. |
| 15276536 | Result | Chen YF, Tsai WC, Lin CC, Tsai LY, Lee CS, Huang CH, Pan PC, Chen ML. Effect of leukocyte depletion on endothelial cell activation and transendothelial migration of leukocytes during cardiopulmonary bypass. Ann Thorac Surg. 2004 Aug;78(2):634-42; discussion 642-3. doi: 10.1016/j.athoracsur.2004.02.091. |
| Oct 10, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 1, 2021 | Sep 9, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D018805 | Sepsis |
| D009102 | Multiple Organ Failure |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided