An interventional study of Cytokine adsorber filter and Extracorporeal hemoperfusion cartridge in Acute Respiratory Distress Syndrome, Septic Shock and Sepsis, sponsored by National Research Center for Cardiac Surgery, Kazakhstan. Status unknown at 1 site in Kazakhstan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-09-13.
Sponsored by National Research Center for Cardiac Surgery, Kazakhstan · Not applicable, Interventional, and Treatment
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
The goal of the study. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
Objectives of the study. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and / or respiratory failure.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
The implementation of this project will improve the effectiveness of surgical treatment and reduce the level of complications and mortality among patients with heart failure and heart failure in the terminal stage.
2.2. The goal of the program. Improvement of organ-substituting technologies in the treatment of heart and respiratory failure.
2.3. Objectives of the program. Objective 1. To study the restoration of organ function during implantation of extracorporeal membrane oxygenation (ECMO), as an organ replacement, in cardiac and/or respiratory failure.
Subtask 1.1. Evaluation of the recovery of organ function during ECMO using extracorporal hemo correction procedure.
Subtask 1.2. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal cytokine adsorber.
Subtask 1.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when conducting ECMO using the extracorporeal hemoperfusion cartridge.
Objective 2. To study the results of applying organ-substituting technologies in the treatment of sepsis.
Subtask 2.1. Assessment of the recovery of organ function in the application of extracorporal hemo correction in septic patients.
Subtask 2.2. Evaluation of the normalization of the organism immune response and restoration of organ function when using the extracorporeal cytokine adsorber in septic patients.
Subtask 2.3. Evaluation of the normalization of the organism's immune response and restoration of organ function when using the extracorporeal hemoperfusion cartridge.
In this study, will be developed methods to restore the function of affected organs after implantation of ECMO and patients with sepsis in combination with extracorporeal hem correction, which will improve the results of surgical treatment of patients with end-cardiac and respiratory failure.
New methods developed to restore the function of affected organs after implantation of mechanical support devices and patients with sepsis will be of great importance both for Kazakhstan and for countries with similar categories of patients, which will improve the efficiency of surgical treatment and reduce the level of complications and mortality.
Clinical research data will form the basis of practical protocols for extracorporeal membrane oxygenation (ECMO) and patients with sepsis, which will improve organ repair, reduce postoperative complications, improve quality of life and reduce mortality after surgery.
Research methods and ethical issues Patients before implantation of ECMO and/or patients with sepsis will be enrolled in the study after giving a written, signed informed consent.
The participants will be randomized into 3 groups:
The investigators will collect demographic, clinical, and laboratory data about patients before, during, and after the operation The incidence of early cellular or humoral rejection, length of ventilation, ICU and hospital stay, the use of vasopressors and inotropes in the perioperative period, and incidence of perioperative complications and survival will be documented.
The level of cytokines (IL-1, IL-6, IL-8, IL-10, tumor necrosis factor-alfa) and complements before, during, and after the use of ECMO, patients with sepsis will be determined if the investigators find the relevant differences between the two groups in clinical variables.
Study Design Study Type: Interventional (Clinical Trial) Estimated Enrollment: 90 Participants Allocation: randomized Interventional Model: Parallel assignment Masking: None (Open Label)
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →National Research Center for Cardiac Surgery, Kazakhstan is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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ICU patients with ECMO:
ICU patients with the septic shock of medical origin:
Exclusion Criteria:
ICU patients with ECMO:
ICU patients with the septic shock of medical origin:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
Device: Cytokine adsorber filter
Cytokine adsorber filter will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
Device: Cytokine adsorber filter
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients on ECMO)
Device: Extracorporeal hemoperfusion cartridge
Extracorporeal hemoperfusion cartridge will be installed into the (hemodialysis or cardiopulmonary bypass (CPB) (15 patients with sepsis)
Device: Extracorporeal hemoperfusion cartridge
No filter will be installed into the ECMO in this study group (15 patients)
No filter will be installed into the patient with sepsis (15 patients)
• 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.
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.
Time frame: 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.
Time frame: 24-48 hours of septic shock
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.
Time frame: 6-24 hours
Ventilator free days (VFD) - ECMO patients
ventilator days. VFD=0, if the patient dies in the first 30 days after randomization
Time frame: 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.
Time frame: 30 days
Difference of d-dimers - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Difference of Serum lactate - ECMO patients
Comparison to enrollment or between 3 groups at 24, 48, 72 h
Time frame: 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)
Time frame: 24, 48, 72 hours
serious adverse device effects - ECMO patients
serious complications or malfunctions related to the CytoSorb device
Time frame: 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
Time frame: 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
Time frame: 30 days
adverse event of special interest: bleeding complications - ECMO patients
major bleeding events
Time frame: 30 days
Difference of serum interleukin-6 level - Patients with septic shock
Comparison to enrollment or between 3 groups at 48, 72 h
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 24, 48, 72 hours
Overall survival time
Overall survival time, defined as time from randomization to death. The time will be censored at the time of last visit for surviving patients.
Time frame: 30 days
Days on intensive care unit (ICU)
Days on intensive care unit (ICU)
Time frame: 30 days
Vasopressor dosage
Vasopressor dosage of adrenaline, noradrenaline, vasopressin, and dobutamine at 24, 48,72 h
Time frame: 24, 48, 72 hours
Fluid substitution and fluid balance
Total fluid\[ml\] substitution and fluid balance \[ml\] at 24, 48, 72 h
Time frame: 24, 48, 72 hours
Length of hospital stay
Days at hospital
Time frame: up to 1 months
Mortality
The period of occurrence of mortality
Time frame: First 72 hours
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 01.01.2021 - 31.12.2023
Access criteria: All patients will receive voluntary informed consent of the established sample with permission to use clinical data for scientific purposes. In addition, the study will be strictly controlled by researchers for the absence of plagiarism, falsification and fabrication of data in order to achieve the most ethical conduct of the study. The obtained patient data will be kept strictly confidential, ensuring privacy by strictly limited access to data, de-identification of data and destruction after the end of the study.
Data sharing details ↗ · heartcenter.kz
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Respiratory Distress Syndrome →
National Research Center for Cardiac Surgery, Kazakhstan