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)

Abrams D, Garan AR, Abdelbary A, Bacchetta M, Bartlett RH, Beck J, Belohlavek J, Chen YS, Fan E, Ferguson ND, Fowles JA, Fraser J, Gong M, Hassan IF, Hodgson C, Hou X, Hryniewicz K, Ichiba S, Jakobleff WA, Lorusso R, MacLaren G, McGuinness S, Mueller T, P — View Citation

Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. Review. — View Citation

Bellomo R, Baldwin I, Ronco C. Extracorporeal blood purification therapy for sepsis and systemic inflammation: its biological rationale. Contrib Nephrol. 2001;(132):367-74. Review. — View Citation

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, Jiménez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Lon — View Citation

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; discussi — View Citation

Cruz DN, Antonelli M, Fumagalli R, Foltran F, Brienza N, Donati A, Malcangi V, Petrini F, Volta G, Bobbio Pallavicini FM, Rottoli F, Giunta F, Ronco C. Early use of polymyxin B hemoperfusion in abdominal septic shock: the EUPHAS randomized controlled tria — View Citation

David S, Thamm K, Schmidt BMW, Falk CS, Kielstein JT. Effect of extracorporeal cytokine removal on vascular barrier function in a septic shock patient. J Intensive Care. 2017 Jan 21;5:12. doi: 10.1186/s40560-017-0208-1. eCollection 2017. — View Citation

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, — View Citation

Friesecke S, Träger K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schum — View Citation

Hetz H, Berger R, Recknagel P, Steltzer H. Septic shock secondary to ß-hemolytic streptococcus-induced necrotizing fasciitis treated with a novel cytokine adsorption therapy. Int J Artif Organs. 2014 May;37(5):422-6. doi: 10.5301/ijao.5000315. Epub 2014 A — View Citation

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. — View Citation

Hotchkiss RS, Monneret G, Payen D. Sepsis-induced immunosuppression: from cellular dysfunctions to immunotherapy. Nat Rev Immunol. 2013 Dec;13(12):862-74. doi: 10.1038/nri3552. Epub 2013 Nov 15. Review. — View Citation

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. Review. — View Citation

Hunt SA. Taking heart--cardiac transplantation past, present, and future. N Engl J Med. 2006 Jul 20;355(3):231-5. Erratum in: N Engl J Med. 2006 Aug 31;355(9):967. — View Citation

Iskander KN, Osuchowski MF, Stearns-Kurosawa DJ, Kurosawa S, Stepien D, Valentine C, Remick DG. Sepsis: multiple abnormalities, heterogeneous responses, and evolving understanding. Physiol Rev. 2013 Jul;93(3):1247-88. doi: 10.1152/physrev.00037.2012. — View Citation

Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M. Feasibility study of cytokine removal by hemoadsorption in brain-dead humans. Crit Care Med. 2008 Jan;36(1):268-72. — View Citation

Khwannimit B, Bhurayanontachai R. The direct costs of intensive care management and risk factors for financial burden of patients with severe sepsis and septic shock. J Crit Care. 2015 Oct;30(5):929-34. doi: 10.1016/j.jcrc.2015.05.011. Epub 2015 May 20. — View Citation

Kogelmann K, Jarczak D, Scheller M, Drüner M. Hemoadsorption by CytoSorb in septic patients: a case series. Crit Care. 2017 Mar 27;21(1):74. doi: 10.1186/s13054-017-1662-9. — View Citation

Kwan A, Hubank M, Rashid A, Klein N, Peters MJ. Transcriptional instability during evolving sepsis may limit biomarker based risk stratification. PLoS One. 2013;8(3):e60501. doi: 10.1371/journal.pone.0060501. Epub 2013 Mar 27. — View Citation

László I, Trásy D, Molnár Z, Fazakas J. Sepsis: From Pathophysiology to Individualized Patient Care. J Immunol Res. 2015;2015:510436. doi: 10.1155/2015/510436. Epub 2015 Jul 15. Review. — View Citation

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. Circulati — View Citation

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 Lu — View Citation

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. Review. — View Citation

Moreno R, Vincent JL, Matos R, Mendonça A, Cantraine F, Thijs L, Takala J, Sprung C, Antonelli M, Bruining H, Willatts S. The use of maximum SOFA score to quantify organ dysfunction/failure in intensive care. Results of a prospective, multicentre study. W — View Citation

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 sil — View Citation

Nemeth E, Kovacs E, Racz K, Soltesz A, Szigeti S, Kiss N, Csikos G, Koritsanszky KB, Berzsenyi V, Trembickij G, Fabry S, Prohaszka Z, Merkely B, Gal J. Impact of intraoperative cytokine adsorption on outcome of patients undergoing orthotopic heart transpl — View Citation

Nylen ES, Whang KT, Snider RH Jr, Steinwald PM, White JC, Becker KL. Mortality is increased by procalcitonin and decreased by an antiserum reactive to procalcitonin in experimental sepsis. Crit Care Med. 1998 Jun;26(6):1001-6. — View Citation

Paolone S. Extracorporeal Membrane Oxygenation (ECMO) for Lung Injury in Severe Acute Respiratory Distress Syndrome (ARDS): Review of the Literature. Clin Nurs Res. 2017 Dec;26(6):747-762. doi: 10.1177/1054773816677808. Epub 2016 Nov 11. Review. — View Citation

Peng ZY, Carter MJ, Kellum JA. Effects of hemoadsorption on cytokine removal and short-term survival in septic rats. Crit Care Med. 2008 May;36(5):1573-7. doi: 10.1097/CCM.0b013e318170b9a7. — View Citation

Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmelé T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA. Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sep — View Citation

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 — View Citation

Riedel S. Procalcitonin and the role of biomarkers in the diagnosis and management of sepsis. Diagn Microbiol Infect Dis. 2012 Jul;73(3):221-7. doi: 10.1016/j.diagmicrobio.2012.05.002. Review. — View Citation

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. Review. — View Citation

Schädler D, Pausch C, Heise D, Meier-Hellmann A, Brederlau J, Weiler N, Marx G, Putensen C, Spies C, Jörres A, Quintel M, Engel C, Kellum JA, Kuhlmann MK. The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic pa — View Citation

Sogayar AM, Machado FR, Rea-Neto A, Dornas A, Grion CM, Lobo SM, Tura BR, Silva CL, Cal RG, Beer I, Michels V, Safi J, Kayath M, Silva E; Costs Study Group - Latin American Sepsis Institute. A multicentre, prospective study to evaluate costs of septic pat — View Citation

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. — View Citation

Tozzi P, Hullin R. Mechanical circulatory support for destination therapy. Swiss Med Wkly. 2016 Mar 5;146:w14267. doi: 10.4414/smw.2016.14267. eCollection 2016. Review. — View Citation

Trásy D, Molnár Z. Procalcitonin - Assisted Antibiotic Strategy in Sepsis. EJIFCC. 2017 May 1;28(2):104-113. eCollection 2017 May. — View Citation

Trásy D, Tánczos K, Németh M, Hankovszky P, Lovas A, Mikor A, László I, Hajdú E, Osztroluczki A, Fazakas J, Molnár Z; EProK study group. Early procalcitonin kinetics and appropriateness of empirical antimicrobial therapy in critically ill patients: A pros — View Citation

Tschaikowsky K, Sägner S, Lehnert N, Kaul M, Ritter J. Endothelin in septic patients: effects on cardiovascular and renal function and its relationship to proinflammatory cytokines. Crit Care Med. 2000 Jun;28(6):1854-60. — View Citation

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 — View Citation

* 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