Acute Respiratory Distress SyndromeOSTNCT05042622
Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
A study testing Cytokine adsorber filter and Extracorporeal hemoperfusion cartridge in people with Acute Respiratory Distress Syndrome and Septic Shock, run by National Research Center for Cardiac Surgery, Kazakhstan at 1 site in Kazakhstan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Septic Shock, Sepsis
- What is being tested?
- Cytokine adsorber filter and Extracorporeal hemoperfusion cartridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Jan 2021to 31 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
- -
- ICU patients with ECMO:
- Hemodynamic support with vasopressors
- Procalcitonin level ≥ 1 ng/ml
- Invasive hemodynamic monitoring
- Written informed content
Show all 12Show fewer
- ICU patients with the septic shock of medical origin:
- Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg)
- Hemodynamic support with vasopressors
- Procalcitonin level ≥ 1 ng/ml
- Invasive hemodynamic monitoring
- Written informed content
Who cannot join
- ICU patients with ECMO:
- age < 18 years
- acute liver or kidney failure straight before transplantation
- the patient declines to participate in the study
- ICU patients with the septic shock of medical origin:
- Patients under 18 years
Show all 15Show fewer
- Pregnancy (bHCG test positivity)
- Surgical intervention in context with the septic insult New York Heart Association IV heart failure
- Acute coronary syndrome
- Acute hematological malignancies
- Immunosuppression, systemic steroid therapy (>10mg prednisolone/day)
- Human immunodeficiency virus infection (HIV) and active AIDS
- Patients with donated organs
- Thrombocytopenia (<20.000/ml)
- More than 10%-of body surface area with third-degree burn
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
National Research Center for Cardiac Surgery
Astana, 010000
Timur Lesbekov, PhD, MD, +77019659151, lesbekovt@mail.ru
Zhuldyz Nurmykhametova, MD, +77781115377, zhyzik-nur@mail.ru
About this study
Official title: Innovative Solutions to Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
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.
Read the detailed description
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients.
Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients.
Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge.
In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure.
New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality.
Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery.
Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into 3 groups:
- Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
- Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
- Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO subgroup - E, septic patients - subgroup F.
The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented.
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables.
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
- Conditions
- Acute Respiratory Distress Syndrome, Septic Shock, Sepsis
- Being tested
- Cytokine adsorber filter, Extracorporeal hemoperfusion cartridge
- Keywords
- Organ-substituting technologies, Heart failure, Pulmonary failure, Sepsis, Extracorporeal membrane oxygenation, Adsorber
- Medical subject headings
- Respiratory Distress Syndrome, Shock, Septic, Sepsis, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine adsorber filterDevice
- Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
Extracorporeal hemoperfusion cartridgeDevice
- Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
| Study group | Role | What they receive |
|---|---|---|
| Cytokine adsorber patients on ECMO | Experimental | Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) Receives: Device: Cytokine adsorber filter |
| Cytokine adsorber patients with sepsis | Experimental | Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis) Receives: Device: Cytokine adsorber filter |
| Extracorporeal hemoperfusion cartridge patients on ECMO | Experimental | Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) Receives: Device: Extracorporeal hemoperfusion cartridge |
| Extracorporeal hemoperfusion cartridge patients with sepsis | Experimental | Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis) Receives: Device: Extracorporeal hemoperfusion cartridge |
| Control (subgroups)1 | No intervention | No filter will be installed into the ECMO in this study group (15 patients) |
| Control (subgroups) 2 | No intervention | No filter will be installed into the patient with sepsis (15 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24-48 hours of septic shock
Secondary outcomes (14)
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.
Measured: 6-24 hours
Ventilator free days (VFD) - ECMO patients
ventilator days. VFD=0, if the patient dies in the first 30 days after randomization
Measured: 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.
Measured: 30 days
Difference of d-dimers - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Measured: 24, 48, 72 hours
Difference of Serum lactate - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Measured: 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)
Measured: 24, 48, 72 hours
serious adverse device effects - ECMO patients
serious complications or malfunctions related to the CytoSorb device
Measured: 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
Measured: 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
Measured: 30 days
adverse event of special interest: bleeding complications - ECMO patients
major bleeding events
Measured: 30 days
Difference of serum interleukin-6 level - Patients with septic shock
Comparison to enrollment or between 3 groups at 48, 72 h
Measured: 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
Measured: 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
Measured: 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
Measured: 24, 48, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
- Masking
- None (open label)
- Enrolment
- 90 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, Timur Lesbekov, National Research Center for Cardiac Surgery, Kazakhstan
- Investigators
- Timur Lesbekov, PhD, MD, Principal investigator, National research Center for Cardiac Surgery JSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042622
- Sponsor's protocol ID
- version 1.1
- Acronym
- OST
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 23725873Hunt 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 25242124Banner NR, Thomas HL, Curnow E, Hussey JC, Rogers CA, Bonser RS; Steering Group of the United Kingdom Cardiothoracic Transplant Audit. The importance of cold and warm cardiac ischemia for survival after heart transplantation. Transplantation. 2008 Aug 27;86(4):542-7. doi: 10.1097/TP.0b013e31818149b9.
PubMed 18724223Russo MJ, Iribarne A, Hong KN, Ramlawi B, Chen JM, Takayama H, Mancini DM, Naka Y. Factors associated with primary graft failure after heart transplantation. Transplantation. 2010 Aug 27;90(4):444-50. doi: 10.1097/TP.0b013e3181e6f1eb.
PubMed 20622755Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T; Society for Cardiovascular Angiography and Interventions (SCAI); Heart Failure Society of America (HFSA); Society for Thoracic Surgeons (STS); American Heart Association (AHA); American College of Cardiology (ACC). 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention). J Card Fail. 2015 Jun;21(6):499-518. doi: 10.1016/j.cardfail.2015.03.002.
PubMed 26036425Mugford M, Elbourne D, Field D. Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD001340. doi: 10.1002/14651858.CD001340.pub2.
PubMed 18646070Stretch R, Sauer CM, Yuh DD, Bonde P. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958.
PubMed 25277608McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
PubMed 26686427Maxwell BG, Powers AJ, Sheikh AY, Lee PH, Lobato RL, Wong JK. Resource use trends in extracorporeal membrane oxygenation in adults: an analysis of the Nationwide Inpatient Sample 1998-2009. J Thorac Cardiovasc Surg. 2014 Aug;148(2):416-21.e1. doi: 10.1016/j.jtcvs.2013.09.033. Epub 2013 Nov 1.
PubMed 24183903Tramm R, Ilic D, Davies AR, Pellegrino VA, Romero L, Hodgson C. Extracorporeal membrane oxygenation for critically ill adults. Cochrane Database Syst Rev. 2015 Jan 22;1(1):CD010381. doi: 10.1002/14651858.CD010381.pub2.
PubMed 25608845Chang CH, Chen HC, Caffrey JL, Hsu J, Lin JW, Lai MS, Chen YS. Survival Analysis After Extracorporeal Membrane Oxygenation in Critically Ill Adults: A Nationwide Cohort Study. Circulation. 2016 Jun 14;133(24):2423-33. doi: 10.1161/CIRCULATIONAHA.115.019143. Epub 2016 May 19.
PubMed 27199466Feldman 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.
PubMed 23352391Khwannimit 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 26051981
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Solutions to Organ-substituting Technologies in the Treatment of Heart and Pulmonary Failure
- ClinicalTrials.gov ID
- NCT05042622
- Acronym / sponsor ID
- OST / version 1.1
- Conditions
- Acute Respiratory Distress Syndrome, Septic Shock, Sepsis
- Keywords
- Organ-substituting technologies, Heart failure, Pulmonary failure, Sepsis, Extracorporeal membrane oxygenation, Adsorber
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 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
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Sep 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 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.
Detailed description
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients.
Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients.
Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge.
In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure.
New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality.
Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery.
Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into 3 groups:
- Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
- Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
- Control group #3 without using extracorporeal adsorber (30 patients): patients on ECMO subgroup - E, septic patients - subgroup F.
The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented.
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables.
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| Cytokine adsorber patients on ECMO | Experimental | Device: Cytokine adsorber filterCytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) |
| Cytokine adsorber patients with sepsis | Experimental | Device: Cytokine adsorber filterCytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis) |
| Extracorporeal hemoperfusion cartridge patients on ECMO | Experimental | Device: Extracorporeal hemoperfusion cartridgeExtracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO) |
| Extracorporeal hemoperfusion cartridge patients with sepsis | Experimental | Device: Extracorporeal hemoperfusion cartridgeExtracorporeal 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) |
| Control (subgroups) 2 | No intervention | –No filter will be installed into the patient with sepsis (15 patients) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- Hemodynamic support with vasopressors
- Procalcitonin level ≥ 1 ng/ml
- Invasive hemodynamic monitoring
- Written informed content
Key exclusion criteria (15 listed)
- ICU patients with ECMO:
- Patients under 18 years
- Pregnancy (bHCG test positivity)
- Surgical intervention in context with the septic insult New York Heart Association IV heart failure
- Acute coronary syndrome
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 |
|---|---|---|
| Cytokine adsorber filter• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B. | Device | Cytokine adsorber patients on ECMO, Cytokine adsorber patients with sepsis |
| Extracorporeal hemoperfusion cartridge• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D. | Device | Extracorporeal hemoperfusion cartridge patients on ECMO, Extracorporeal hemoperfusion cartridge patients with sepsis |
Primary outcome
Difference of Cytokine response - ECMO patients
Time frame: 6-24 hours
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.
Difference of Cytokine response - Patients with septic shock
Time frame: 24-48 hours of 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.
14 secondary outcomes
Inflammatory reaction - Patients with septic shock
Time frame: 6-24 hours
Ventilator free days (VFD) - ECMO patients
Time frame: 30 days
Time to extubation from ventilation and explantation from ECMO - ECMO patients
Time frame: 30 days
Difference of d-dimers - ECMO patients
Time frame: 24, 48, 72 hours
Difference of Serum lactate - ECMO patients
Time frame: 24, 48, 72 hours
SOFA-Score - ECMO patients
Time frame: 24, 48, 72 hours
serious adverse device effects - ECMO patients
Time frame: 30 days
adverse event of special interest: air in the ECMO system - ECMO patients
Time frame: 30 days
adverse event of special interest: blood-clotting in the ECMO system
Time frame: 30 days
adverse event of special interest: bleeding complications - ECMO patients
Time frame: 30 days
Difference of serum interleukin-6 level - Patients with septic shock
Time frame: 48, 72 hours
Difference of serum interleukin-1β level - Patients with septic shock
Time frame: 24, 48, 72 hours
Difference of serum interleukin-10 level - Patients with septic shock
Time frame: 24, 48, 72 hours
Difference of serum procalcitonin level - Patients with septic shock
Time frame: 24, 48, 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 23725873Venet 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.
- 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 18724223Banner NR, Thomas HL, Curnow E, Hussey JC, Rogers CA, Bonser RS; Steering Group of the United Kingdom Cardiothoracic Transplant Audit. The importance of cold and warm cardiac ischemia for survival after heart transplantation. Transplantation. 2008 Aug 27;86(4):542-7. doi: 10.1097/TP.0b013e31818149b9.
- Results publication: PubMed 20622755Russo MJ, Iribarne A, Hong KN, Ramlawi B, Chen JM, Takayama H, Mancini DM, Naka Y. Factors associated with primary graft failure after heart transplantation. Transplantation. 2010 Aug 27;90(4):444-50. doi: 10.1097/TP.0b013e3181e6f1eb.
- Results publication: PubMed 26036425Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T; Society for Cardiovascular Angiography and Interventions (SCAI); Heart Failure Society of America (HFSA); Society for Thoracic Surgeons (STS); American Heart Association (AHA); American College of Cardiology (ACC). 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care (Endorsed by the American Heart Association, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention). J Card Fail. 2015 Jun;21(6):499-518. doi: 10.1016/j.cardfail.2015.03.002.
- Results publication: PubMed 18646070Mugford M, Elbourne D, Field D. Extracorporeal membrane oxygenation for severe respiratory failure in newborn infants. Cochrane Database Syst Rev. 2008 Jul 16;2008(3):CD001340. doi: 10.1002/14651858.CD001340.pub2.
- Results publication: PubMed 25277608Stretch R, Sauer CM, Yuh DD, Bonde P. National trends in the utilization of short-term mechanical circulatory support: incidence, outcomes, and cost analysis. J Am Coll Cardiol. 2014 Oct 7;64(14):1407-15. doi: 10.1016/j.jacc.2014.07.958.
- Results publication: PubMed 26686427McCarthy FH, McDermott KM, Kini V, Gutsche JT, Wald JW, Xie D, Szeto WY, Bermudez CA, Atluri P, Acker MA, Desai ND. Trends in U.S. Extracorporeal Membrane Oxygenation Use and Outcomes: 2002-2012. Semin Thorac Cardiovasc Surg. 2015 Summer;27(2):81-8. doi: 10.1053/j.semtcvs.2015.07.005. Epub 2015 Jul 22.
- Results publication: PubMed 24183903Maxwell BG, Powers AJ, Sheikh AY, Lee PH, Lobato RL, Wong JK. Resource use trends in extracorporeal membrane oxygenation in adults: an analysis of the Nationwide Inpatient Sample 1998-2009. J Thorac Cardiovasc Surg. 2014 Aug;148(2):416-21.e1. doi: 10.1016/j.jtcvs.2013.09.033. Epub 2013 Nov 1.
- Results publication: PubMed 25608845Tramm R, Ilic D, Davies AR, Pellegrino VA, Romero L, Hodgson C. Extracorporeal membrane oxygenation for critically ill adults. Cochrane Database Syst Rev. 2015 Jan 22;1(1):CD010381. doi: 10.1002/14651858.CD010381.pub2.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Timur Lesbekov, 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 Cytokine adsorber filter and Extracorporeal hemoperfusion cartridge in people with Acute Respiratory Distress Syndrome and Septic Shock, 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 12 inclusion and 15 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 13 Sep 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 Rymbay Kaliyev, MD (+77055965060, rymbay@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Cytokine response - ECMO patients (time frame: 6-24 hours). The study lists 2 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 NCT05042622, which also lists 44 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 13 Sep 2021.