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Prospective, multi-center, randomized, feasibility clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and treatment with the CytoSorb® device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb Device | Experimental | Standard of care plus treatment with CytSorb device installed on the CPB machine |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb | Device | Cytosorb device use during cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Serious Device Related Adverse Events | The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU. | From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Time in the ICU | Days in ICU, Post Surgery | From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) |
| 30 Day All Cause Mortality | Mortality within 30 Days of Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Complement Factor C3a - 2 Hours Post Start of CPB | Change in complement factor C3a - Sampling at 2 hours post start of CPB | 2 hours post start of cardiac bypass |
| Change in Complement Factor C3a - 3 Hours Post Start of CPB |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Sisk, MSc Pharm | CytSorbents | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | United States | |||
| University of Maryland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37607074 | Derived | Heymann M, Schorer R, Putzu A. The Effect of CytoSorb on Inflammatory Markers in Critically Ill Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Crit Care Med. 2023 Dec 1;51(12):1659-1673. doi: 10.1097/CCM.0000000000006007. Epub 2023 Aug 21. |
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Potential patients had to have a planned 3+ hour bypass time. Isolated coronary bypass graft or single valve procedures were excluded. Cases included were aortic reconstructions, valve repairs, valve replacements and combinations thereof, and permitted combination with coronary bypass graft. Emergency and endocarditis patients were excluded. 52 patients enrolled in the study, of which 6 withdrew from the study.
First Patient In; 8 December, 2015 Last Patient in: 19 August 2016
Mostly university hospitals; all sites had robust cardiac surgery programs
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| ID | Title | Description |
|---|---|---|
| FG000 | CytoSorb Device | Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine CytoSorb: Cytosorb device use during cardiopulmonary bypass |
| FG001 | Control | Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CytoSorb Device | Standard of care plus treatment with CytSorb device installed on the CPB machine CytoSorb: Cytosorb device use during cardiopulmonary bypass |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Serious Device Related Adverse Events | The primary safety endpoint of this trial was to determine the product safety profile through the assessment of serious device related AEs through discharge from the ICU. | All patients who had at least on Adverse Event | Posted | Number | participants | From time of enrollment through ICU discharge (e.g. ICU stay of approximately 4 days) |
|
Adverse events were reported for the 30 day period following Cardiac Surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CytoSorb Device | Standard of care cardiac surgery with CPB plus treatment with CytSorb device installed on the CPB machine CytoSorb: Cytosorb device use during cardiopulmonary bypass |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrilation | Cardiac disorders | MedDra | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Zwischenberger, MD | University of Kentucky College of Medicine | 859-323-6013 | jzwis2@uky.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| From time of enrollment through 30 days post procedure |
| Adverse Event Rates | Total number of Serious Adverse Events | through 30 days |
Change in complement factor C3a - Sampling at 3 hours post start of CPB
| 3 hours post start of CPB |
| Change in Complement Factor C5a - 2 Hours Post Start of CPB | Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline | 2 hours post start of cardiac bypass |
| Baltimore |
| Maryland |
| United States |
| Baystate Medical | Springfield | Massachusetts | United States |
| Cooper University Hospital | Camden | New Jersey | United States |
| Columbia University | New York | New York | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States |
| Baylor College of Medicine | Houston | Texas | United States |
Standard of care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time in the ICU | Days in ICU, Post Surgery | Posted | Mean | Standard Deviation | Days | From the end of cardiopulmonary bypass procedure through ICU discharge (e.g. ICU stay of approximately 4 days) |
|
|
|
| Secondary | 30 Day All Cause Mortality | Mortality within 30 Days of Surgery | All patients who were randomized to trial and had a surgical procedure | Posted | Number | participants | From time of enrollment through 30 days post procedure |
|
|
|
| Secondary | Adverse Event Rates | Total number of Serious Adverse Events | Total number of Serious Adverse Events | Posted | Number | SAE | through 30 days |
|
|
|
| Other Pre-specified | Change in Complement Factor C3a - 2 Hours Post Start of CPB | Change in complement factor C3a - Sampling at 2 hours post start of CPB | Patients with evaluable C3a laboratories | Posted | Mean | Standard Deviation | ng/ml | 2 hours post start of cardiac bypass |
|
|
|
| Other Pre-specified | Change in Complement Factor C3a - 3 Hours Post Start of CPB | Change in complement factor C3a - Sampling at 3 hours post start of CPB | Patients with evaluable C3a laboratory values at 3 hours post start of CPB | Posted | Mean | Standard Deviation | ng/ml | 3 hours post start of CPB |
|
|
|
| Other Pre-specified | Change in Complement Factor C5a - 2 Hours Post Start of CPB | Change in complement factor C5a - Sampling at 2 hours post start of CPB, change from baseline | Patients with evaluable C5a laboratories | Posted | Mean | Standard Deviation | ng/ml | 2 hours post start of cardiac bypass |
|
|
|
| 2 |
| 23 |
| 16 |
| 23 |
| 23 |
| 23 |
| EG001 | Control | Standard of care, cardiac surgery patients, cardiac bypass with no CytoSorb device | 1 | 23 | 11 | 23 | 21 | 23 |
| Atrial flutter | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Right ventricular dysfunction | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Cardiac perforation | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Myocardial stunning | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Pulseless electrical activity | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Acute Lung Injury | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Atrial Fibrilation | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Atrioventricular block first degree | Cardiac disorders | Medra 10.1 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | Medra 10.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Medra 10.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | Medra 10.1 | Systematic Assessment |
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| Hypernatremia | Metabolism and nutrition disorders | Medra 10.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Medra 10.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | Medra 10.1 | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Medra 10.1 | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Medra 10.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Atalectasis | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | Medra 10.1 | Systematic Assessment |
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| Haemorrhage | Vascular disorders | Medra 10.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | Medra 10.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Medra 10.1 | Systematic Assessment |
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| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Medra 10.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Medra 10.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | Medra 10.1 | Systematic Assessment |
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| Tranaminases increased | Investigations | Medra 10.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | Medra 10.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Medra 10.1 | Systematic Assessment |
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