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| Name | Class |
|---|---|
| Ministry of Education and Science, Republic of Kazakhstan | OTHER_GOV |
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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 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:
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytokine adsorber patients on ECMO | Experimental | Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) |
|
| Cytokine adsorber patients with sepsis | Experimental | Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis) |
|
| Extracorporeal hemoperfusion cartridge patients on ECMO | Experimental | Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) |
|
| Extracorporeal hemoperfusion cartridge patients with sepsis | Experimental | Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis) |
|
| Control (subgroups)1 | No Intervention | No filter will be installed into the ECMO in this study group (15 patients) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine adsorber filter | Device | • Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Cytokine response - ECMO patients | Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) before initiation of ECMO, 2 hours after initiation ECMO support, at explantation of ECMO support, 6-12-24 hours after explantation of ECMO support. | 6-24 hours |
| Difference of Cytokine response - Patients with septic shock | Level of procalcitonin, Level of C-reactive protein, Level of interleukin-1, Level of interleukin-6, Level of interleukin-8, Level of interleukin-10, Level of Tumor Necrosis Factor- αinterleukin-8, interleukin-10, Tumor Necrosis Factor- α at 24, 48 hours. | 24-48 hours of septic shock |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory reaction - Patients with septic shock | Level of C reactive protein (CRP), white blood cells and procalcitonin immediately after induction of anesthesia, before initiation of adsorber, 2 hours after initiation of adsorber, at termination of adsorber, 6-12-24 hours after wean of adsorber. | 6-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival time | Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients. | 30 days |
| Days on intensive care unit (ICU) |
Inclusion Criteria:
-
ICU patients with ECMO:
ICU patients with the septic shock of medical origin:
Exclusion Criteria:
ICU patients with ECMO:
ICU patients with the septic shock of medical origin:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rymbay Kaliyev, MD | Contact | +77055965060 | rymbay@mail.ru | |
| Zhuldyz Nurmykhametova, MD | Contact | +77781115377 | zhyzik-nur@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Timur Lesbekov, 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 |
|---|---|---|---|
| 23725873 | Background | 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. | |
| 16855261 | Result | 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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all collected IPD
01.01.2021 - 31.12.2023
All patients will receive voluntary informed consent of the established sample with permission to use clinical data for scientific purposes. In addition, the study will be strictly controlled by researchers for the absence of plagiarism, falsification and fabrication of data in order to achieve the most ethical conduct of the study. The obtained patient data will be kept strictly confidential, ensuring privacy by 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 | Apr 15, 2021 | Sep 6, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2021 | Aug 25, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007239 | Infections |
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Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
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| Control (subgroups) 2 | No Intervention | No filter will be installed into the patient with sepsis (15 patients) |
| Extracorporeal hemoperfusion cartridge | Device | • Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D. |
|
| Ventilator free days (VFD) - ECMO patients |
ventilator days. VFD=0, if the patient dies in the first 30 days after randomization |
| 30 days |
| Time to extubation from ventilation and explantation from ECMO - ECMO patients | Time to extubation from ventilation and explantation from ECMO. Death under ventilation and/or ECMO will be analyzed as a competing event. The time will be censored at the time of last visit for surviving patients under ventilation and/or ECMO. | 30 days |
| Difference of d-dimers - ECMO patients | Comparison to enrollment or between 3 groups at 24, 48, 72 h | 24, 48, 72 hours |
| Difference of Serum lactate - ECMO patients | Comparison to enrollment or between 3 groups at 24, 48, 72 h | 24, 48, 72 hours |
| SOFA-Score - ECMO patients | 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 |
| serious adverse device effects - ECMO patients | serious complications or malfunctions related to the CytoSorb device | 30 days |
| adverse event of special interest: air in the ECMO system - ECMO patients | unintended air in the ECMO system during operation of the device | 30 days |
| adverse event of special interest: blood-clotting in the ECMO system | unintended blood-clotting in the ECMO system during operation of the device | 30 days |
| adverse event of special interest: bleeding complications - ECMO patients | major bleeding events | 30 days |
| Difference of serum interleukin-6 level - Patients with septic shock | Comparison to enrollment or between 3 groups at 48, 72 h | 48, 72 hours |
| Difference of serum interleukin-1β level - Patients with septic shock | Comparison to enrollment or between 3 groups at 24, 48, 72 h | 24, 48, 72 hours |
| Difference of serum interleukin-10 level - Patients with septic shock | Comparison to enrollment or between 3 groups at 24, 48, 72 h | 24, 48, 72 hours |
| Difference of serum procalcitonin level - Patients with septic shock | Comparison to enrollment or between 3 groups at 24, 48, 72 h | 24, 48, 72 hours |
Days on intensive care unit (ICU)
| 30 days |
| Vasopressor dosage | Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h | 24, 48, 72 hours |
| Fluid substitution and fluid balance | Total fluid[ml] substitution and fluid balance [ml] at 24, 48, 72 h | 24, 48, 72 hours |
| Length of hospital stay | Days at hospital | up to 1 months |
| Mortality | The period of occurrence of mortality | First 72 hours |
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| 11395904 | Result | Bellomo R, Baldwin I, Ronco C. Extracorporeal blood purification therapy for sepsis and systemic inflammation: its biological rationale. Contrib Nephrol. 2001;(132):367-74. doi: 10.1159/000060105. |
| 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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| 28101605 | Result | Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18. |
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| 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. |
| 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. |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |