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Sponsor's decision for business reasons
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Prospective, multi-center, randomized, blinded, pivotal clinical study. Subjects will be randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care plus treatment with the CytoSorb® device.
To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) as defined by Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline definition of acute kidney injury when used intraoperatively with cardiopulmonary bypass (CPB) in subjects undergoing cardiac surgery. The objective of using CytoSorb® treatment in this setting is to provide clinically meaningful improvements in renal function by mitigation of intraoperative injury by removal of nephrotoxic agents such as pfHb and complement. Up to 420 subjects will be enrolled and randomized at a 1:1 ratio at up to 40 investigational sites in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CytoSorb Device | Experimental | Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine |
|
| Control | Placebo Comparator | Standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CytoSorb | Device | To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) | Incidence and severity of AKI in the first 48 hours after CPB, evaluated based on creatinine levels at CPB, 24 & 48h after CPB and urine output up to 48h. | From start of CPB through 48 hours after CPB |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Health Resource Utilization: ICU Duration (Hours) | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | From start of CPB through discharge, average of 8.9 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Gleason, MD | not applicable- Unaffiliated with CytoSorbents | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States | ||
| University of Chicago |
34 Subjects exited study post consent, but pre-procedure: 21 of these were screen failures (20 did not meet eligibility criteria, 1 was reported as Screen failure for reasons other than not meeting the eligibility criteria).
4 were withdrawn due to investigator decision. 2 withdrew consent. 7 exited due to "other reasons."
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| ID | Title | Description |
|---|---|---|
| FG000 | CytoSorb Device | Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2020 | Apr 9, 2024 |
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|
| Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission |
Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. |
| From start of CPB through discharge, average of 8.9 days. |
| Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | From start of CPB through discharge, average of 8.9 days. |
| Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | From start of CPB through discharge, average of 8.9 days. |
| Initiation of Renal Replacement Therapy | Initiation of Renal Replacement Therapy up to 48 Hours post CPB | Up to 48 hours after CPB |
| Chicago |
| Illinois |
| 60637 |
| United States |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Northwell Health: Lennox Hill Hospital | New York | New York | 10075 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27858 | United States |
| The Christ Hospital Linder Research Center | Cincinnati | Ohio | 45219 | United States |
| Ohio State university | Columbus | Ohio | 43210 | United States |
| Integris Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
Standard of care CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| FG002 | Roll in: SOC + CytoSorb Device | Unblinded Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CytoSorb Device | Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| BG001 | Control | Standard of care CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| BG002 | Roll In: CytoSorb Device | Unblinded: Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Smoking History | Number | participants |
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| 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 | Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) | Incidence and severity of AKI in the first 48 hours after CPB, evaluated based on creatinine levels at CPB, 24 & 48h after CPB and urine output up to 48h. | Posted | Count of Participants | Participants | From start of CPB through 48 hours after CPB |
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| Secondary | Summary of Health Resource Utilization: ICU Duration (Hours) | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | safety population analysis. Not all patients' data complete. | Posted | Median | Standard Deviation | hours | From start of CPB through discharge, average of 8.9 days. |
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| Secondary | Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | safety population analysis. Not all patients' data complete. | Posted | Median | Standard Deviation | days | From start of CPB through discharge, average of 8.9 days. |
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| Secondary | Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | safety population analysis. Not all patients' data complete. | Posted | Count of Participants | Participants | From start of CPB through discharge, average of 8.9 days. |
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| Secondary | Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use | Analysis of health resource utilization included parameters such as length of stay in ICU and hospital and need for supportive care measures such as vasopressors, and mechanical ventilation. | safety population analysis. Not all patients' data complete. | Posted | Median | Standard Deviation | hours | From start of CPB through discharge, average of 8.9 days. |
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| Secondary | Initiation of Renal Replacement Therapy | Initiation of Renal Replacement Therapy up to 48 Hours post CPB | Posted | Count of Participants | Participants | Up to 48 hours after CPB |
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Adverse event data was collected from the time of Consent to 30 days post-procedure +/- 5 days.
Throughout the study, the Investigator or designee determined adverse event (AE) occurrences through assessment & regular laboratory testing.
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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 plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) | 1 | 56 | 28 | 56 | 35 | 56 |
| EG001 | Control | Standard of care CytoSorb: To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) | 1 | 60 | 21 | 60 | 44 | 60 |
| EG002 | Roll in: SOC + CytoSorb Device | Unblinded Standard of care plus treatment with CytoSorb device installed on the Cardiopulmonary bypass (CPB) machine CytoSorb: To evaluate the safety of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI) | 0 | 36 | 14 | 36 | 30 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Cardiogenic shock | Cardiac disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | Systematic Assessment |
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| Anaemia postoperative | Injury, poisoning and procedural complications | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Acute Kidney injury | Renal and urinary disorders | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Acute respiratory failure | Renal and urinary disorders | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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Early termination leading to small numbers of subjects analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Darlene Lambert-Christie/ Director, Clinical Operations | Cytosorbents | 732.822.3332 | DLambert-Christie@cytosorbents.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2022 | Apr 9, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Former Smoker |
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| Never Smoked |
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| Title | Measurements |
|---|---|
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| AKI Stage 2 (moderate) |
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| AKI Stage 3 (Severe) |
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| Participants |
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