Cardiogenic ShockNCT05090930
Innovative Technologies for the Treatment of Pulmonary and Heart Failure
A study testing HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection and CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber in people with Cardiogenic Shock and Ventricular Arrythmia, run by National Research Center for Cardiac Surgery, Kazakhstan at 1 site in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiogenic Shock, Ventricular Arrythmia, Cardiac Arrest With Successful Resuscitation
- What is being tested?
- HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection and CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Jan 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
National Research Center For Cardiac Surgery
Astana, 010000
Yuriy Pya, PhD, MD, +77172703100, rp.nrcsc@gmail.com
Zhuldyz Nurmykhametova, MD, +77781115377, zhyzik-nur@mail.ru
About this study
Official title: Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
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.
Read the detailed 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
- Conditions
- Cardiogenic Shock, Ventricular Arrythmia, Cardiac Arrest With Successful Resuscitation, Sepsis, Multiple Organ Failure, Pulmonary Failure
- Being tested
- HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection, CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber
- Keywords
- Anesthesiology, Cardiothoracic surgery, Nephrology, Perfusion, Efferentology
- Medical subject headings
- Shock, Cardiogenic, Sepsis, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionDevice
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 adsorberDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection |
| 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). Receives: Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection |
| 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). Receives: Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection |
| 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). Receives: Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection |
| Intervention team (2/1 groups) | Active comparator | An extracorporeal hemoperfusion device will be installed in the device of the extracorporeal life support system for heart failure.
(10 patients) Receives: Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber |
| 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) Receives: Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber |
| 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) Receives: Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber |
| 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) Receives: Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 24, 48, 72 hours
Extracorporeal life support system with pulmonary and / or heart failure
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Measured: 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)
Measured: 24-48 hours
Patients with left ventricular assist device implantation:vasopressors and / or inotropes
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Measured: first 72 hours
Patients with left ventricular assist device implantation:Renal function
creatinine level
Measured: first 72 hours
Patients with left ventricular assist device implantation:Lactate level
Lactate level
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 24, 48, 72 hours
Secondary outcomes (17)
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.
Measured: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte
Level of leukocyte cells in the bloodstream at 24, 48 hours
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: first 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Jan 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Cardiac Surgery, Kazakhstan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education and Science, Republic of Kazakhstan
- Responsible party
- Principal investigator, Yuriy Pya, National Research Center for Cardiac Surgery, Kazakhstan
- Investigators
- Yuri Pya, PhD, MD, Principal investigator, National research Center for Cardiac Surgery JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090930
- Sponsor's protocol ID
- version01
- Other IDs
- BR10965200
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make IPD and related data dictionaries available.
Publications
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.
PubMed 20413034Maciver 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.
PubMed 22891167Tozzi 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.
PubMed 26945160Paolone 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.
PubMed 27836935Abrams 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, Park PK, Peek G, Pellegrino V, Price S, Rosenzweig EB, Sakamoto T, Salazar L, Schmidt M, Slutsky AS, Spaulding C, Takayama H, Takeda K, Vuylsteke A, Combes A, Brodie D; International ECMO Network (ECMONet) and The Extracorporeal Life Support Organization (ELSO). Position paper for the organization of ECMO programs for cardiac failure in adults. Intensive Care Med. 2018 Jun;44(6):717-729. doi: 10.1007/s00134-018-5064-5. Epub 2018 Feb 15.
PubMed 29450594Hunt 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.
PubMed 16855261Hunt 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.
PubMed 18702960Lund 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.
PubMed 25242124Sogayar 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 patients in Brazilian intensive care units. Pharmacoeconomics. 2008;26(5):425-34. doi: 10.2165/00019053-200826050-00006.
PubMed 18429658Khwannimit 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.
PubMed 26051981Iskander 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.
PubMed 23899564Kwan 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.
PubMed 23544148Akira S, Uematsu S, Takeuchi O. Pathogen recognition and innate immunity. Cell. 2006 Feb 24;124(4):783-801. doi: 10.1016/j.cell.2006.02.015.
PubMed 16497588Hotchkiss 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.
PubMed 24232462Venet 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.
PubMed 23725873
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Innovative Technologies for the Treatment of Pulmonary and Heart Failure to Prolong Human's Life
- ClinicalTrials.gov ID
- NCT05090930
- Acronym / sponsor ID
- version01
- Conditions
- Cardiogenic Shock, Ventricular Arrythmia, Cardiac Arrest With Successful Resuscitation, Sepsis, Multiple Organ Failure, Pulmonary Failure
- Keywords
- Anesthesiology, Cardiothoracic surgery, Nephrology, Perfusion, Efferentology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Research Center for Cardiac Surgery, KazakhstanUniversity, hospital or other
- Collaborators
- Ministry of Education and Science, Republic of Kazakhstan
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention team (1/1 group) | Active comparator | Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionAn 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 | Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionAn 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 | Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionAn 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 | Device: HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionAn 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) | Active comparator | Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorberAn 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 | Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorberAn 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 | Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorberAn 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 | Device: CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorberAn extracorporeal hemoperfusion device will be installed in patients during operations with prolonged artificial circulation, hypothermia, and circulatory arrest. (25 patients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Implantation of intravenous ECMO
- Hemodynamic support with vasopressors and/or tonics;
- Procalcitonin level ≥ 1 ng/ml;
- Invasive hemodynamic monitoring;
- Written informed consent.
Key exclusion criteria (16 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrectionHA330 - 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 | Device | Intervention team (1/1 group), Intervention team (1/2 group), Intervention team (1/3 group), Intervention team (1/4 group) |
| CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorberCytoSorb (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 | Device | Intervention team (2/1 groups), Intervention team (2/2 groups), Intervention team (2/3 groups), Intervention team (2/4 groups) |
Primary outcome
Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response
Time frame: 24-48 hours
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.
Extracorporeal life support system with pulmonary and / or heart failure: SOFA-Score
Time frame: 24, 48, 72 hours
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Extracorporeal life support system with pulmonary and / or heart failure
Time frame: Time: first 72 hours
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Patients with left ventricular assist device implantation: Difference of Cytokine response
Time frame: 24-48 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin)
Patients with left ventricular assist device implantation:vasopressors and / or inotropes
Time frame: first 72 hours
Doses of vasopressors and / or inotropes (µg / h / kg bodyweight)
Patients with left ventricular assist device implantation:Renal function
Time frame: first 72 hours
creatinine level
Patients with left ventricular assist device implantation:Lactate level
Time frame: first 72 hours
Lactate level
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of Cytokine response
Time frame: 24-48 hours
Level of pro- and anti-inflammatory cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa, procalcitonin, C-reactive protein)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: SOFA-Score
Time frame: 24, 48, 72 hours
Sequential Organ Failure Assessment Score at 24, 48, 72 h (values from 6 to 24, where the higher values explain higher disease severity)
Extracorporeal life support system with pulmonary and / or heart failure:Difference of mean arterial pressure
Time frame: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Extracorporeal life support system with pulmonary and / or heart failure: Difference of CVP
Time frame: 24, 48, 72 hours
Comparison of CVP at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
Extracorporeal life support system with pulmonary and / or heart failure: Serum lactate
Time frame: 24, 48, 72 hours
Level of serum lactate at 24, 48, 72 h
Extracorporeal life support system with pulmonary and / or heart failure:Days on ventilator, vasopressor and renal replacement therapy
Time frame: until day 30 post-surgery
Total days on ventilator, vasopressor and renal replacement therapy within 30 days post-surgery will be assessed
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of mean arterial pressure
Time frame: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Difference of CVP
Time frame: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Level of Serum lactate
Time frame: 24, 48, 72 hours
Comparison of mean arterial pressure at 24, 48, 72 hours between between two interventions (CytoSorb and Jafron)
17 secondary outcomes
Extracorporeal life support system with pulmonary and / or heart failure:The level of C-reactive protein (CRP)
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure: Level of leukocyte
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of vasopressors
Time frame: first 48 hours
Patients with left ventricular assist device implantation: The level of C-reactive protein (CRP)
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: Application and dosage of vasopressors
Time frame: first 48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: The level of C-reactive protein (CRP)
Time frame: 24-48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest:Leukocyte function
Time frame: first 48 hours
For operations with prolonged artificial circulation, hypothermia and circulatory arrest: Application and dosage of vasopressors
Time frame: first 48 hours
Extracorporeal life support system with pulmonary and / or heart failure:The level of leukocytes
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:The level of procalcitonin
Time frame: 24-48 hours
Extracorporeal life support system with pulmonary and / or heart failure:Application and dosage of inotropes
Time frame: first 48 hours
Patients with left ventricular assist device implantation: The level of leukocytes
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: The level of procalcitonin
Time frame: 24-48 hours
Patients with left ventricular assist device implantation: Application and dosage of inotropes
Time frame: first 48 hours
For operations with prolonged cardio pulmonary bypass, hypothermia and circulatory arrest: The level of leukocytes
Time frame: 24-48 hours
For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: The level of procalcitonin
Time frame: 24-48 hours
For operations with prolonged cardiopulmonary bypass, hypothermia, and circulatory arrest: Application and dosage of inotropes
Time frame: first 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Results publication: PubMed 20413034Starling 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.
- Results publication: PubMed 22891167Maciver 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.
- Results publication: PubMed 26945160Tozzi 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.
- Results publication: PubMed 27836935Paolone 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.
- Results publication: PubMed 29450594Abrams 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, Park PK, Peek G, Pellegrino V, Price S, Rosenzweig EB, Sakamoto T, Salazar L, Schmidt M, Slutsky AS, Spaulding C, Takayama H, Takeda K, Vuylsteke A, Combes A, Brodie D; International ECMO Network (ECMONet) and The Extracorporeal Life Support Organization (ELSO). Position paper for the organization of ECMO programs for cardiac failure in adults. Intensive Care Med. 2018 Jun;44(6):717-729. doi: 10.1007/s00134-018-5064-5. Epub 2018 Feb 15.
- Results publication: PubMed 16855261Hunt 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.
- Results publication: PubMed 18702960Hunt 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.
- Results publication: PubMed 25242124Lund 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.
- Results publication: PubMed 18429658Sogayar 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 patients in Brazilian intensive care units. Pharmacoeconomics. 2008;26(5):425-34. doi: 10.2165/00019053-200826050-00006.
- Results publication: PubMed 26051981Khwannimit 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.
- Results publication: PubMed 23899564Iskander 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.
- Results publication: PubMed 23544148Kwan 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.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuri Pya, PhD, MD principal investigator
National research Center for Cardiac Surgery JSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HA330 - Jafron Biomedical Co., Ltd., China - extracorporeal hemocorrection and CytoSorb (CytoSorbents Corp., USA) - an extracorporeal cytokine adsorber in people with Cardiogenic Shock and Ventricular Arrythmia, run by National Research Center for Cardiac Surgery, Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuri Pya, PhD, MD (+77172272090, rp.nrcsc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracorporeal life support system with pulmonary and / or heart failure: Cytokine response (time frame: 24-48 hours). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05090930, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.