Trial Outcomes & Findings for CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery (NCT NCT03384875)

Last Updated: 2024-12-04

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

186 participants

Primary outcome timeframe

From start of CPB through 48 hours after CPB

Results posted on

2024-12-04

Participant Flow

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criteria, 1 was reported as Screen failure for reasons other than not meeting the eligibility criteria). 4 were withdrawn due to investigator decision. 2 withdrew consent. 7 exited due to "other reasons."

Participant milestones

Participant milestones
Measure	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)	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)	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)
Overall Study STARTED	56	60	36
Overall Study COMPLETED	54	59	36
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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)	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)	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)
Overall Study Death	1	1	0
Overall Study Reason not provided	1	0	0

Baseline Characteristics

CytoSorb® Reduction of FREee Hemoglobin/Acute Kidney Injury (AKI) During Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)	Total n=152 Participants Total of all reporting groups
Age, Continuous	66.98 years STANDARD_DEVIATION 11.87 • n=5 Participants	64.10 years STANDARD_DEVIATION 11.88 • n=7 Participants	66.14 years STANDARD_DEVIATION 11.84 • n=5 Participants	65.64 years STANDARD_DEVIATION 11.86 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	18 Participants n=7 Participants	9 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	42 Participants n=7 Participants	27 Participants n=5 Participants	107 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	57 Participants n=7 Participants	32 Participants n=5 Participants	142 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	56 Participants n=7 Participants	31 Participants n=5 Participants	138 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	56 participants n=5 Participants	60 participants n=7 Participants	36 participants n=5 Participants	152 participants n=4 Participants
Smoking History Current Smoker	10 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants	15 participants n=4 Participants
Smoking History Former Smoker	19 participants n=5 Participants	28 participants n=7 Participants	16 participants n=5 Participants	63 participants n=4 Participants
Smoking History Never Smoked	27 participants n=5 Participants	30 participants n=7 Participants	17 participants n=5 Participants	74 participants n=4 Participants

PRIMARY outcome

Timeframe: From start of CPB through 48 hours after 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.

Outcome measures

Outcome measures
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) AKI Stage 0	9 Participants	12 Participants	7 Participants
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) AKI Stage 3 (Severe)	9 Participants	15 Participants	6 Participants
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) AKI Stage 1 (Mild)	7 Participants	5 Participants	2 Participants
Incidence and Severity of Acute Kidney Injury (AKI) in the First 48 Hours After Cardiopulmonary Pulmonary Bypass (CPB) AKI Stage 2 (moderate)	31 Participants	28 Participants	21 Participants

SECONDARY outcome

Timeframe: From start of CPB through discharge, average of 8.9 days.

Population: safety population analysis. Not all patients' data complete.

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.

Outcome measures

Outcome measures
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)
Summary of Health Resource Utilization: ICU Duration (Hours)	70.63 hours Standard Deviation 85.55	53.57 hours Standard Deviation 67.60	66.83 hours Standard Deviation 132.87

SECONDARY outcome

Timeframe: From start of CPB through discharge, average of 8.9 days.

Population: safety population analysis. Not all patients' data complete.

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.

Outcome measures

Outcome measures
Measure	CytoSorb Device n=54 Participants 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)	Control n=59 Participants 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)	Roll In: CytoSorb Device n=35 Participants 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)
Summary of Health Resource Utilization: Post-Op Hospital Stay: Date of Discharge - Date of ICU Admission	8 days Standard Deviation 3.9	7 days Standard Deviation 4.7	7 days Standard Deviation 5.2

SECONDARY outcome

Timeframe: From start of CPB through discharge, average of 8.9 days.

Population: safety population analysis. Not all patients' data complete.

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.

Outcome measures

Outcome measures
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)
Summary of Health Resource Utilization: Number of Patients on Vasopressor Medication	44 Participants	48 Participants	32 Participants

SECONDARY outcome

Timeframe: From start of CPB through discharge, average of 8.9 days.

Population: safety population analysis. Not all patients' data complete.

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.

Outcome measures

Outcome measures
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)
Summary of Health Resource Utilization: Duration of Continuous Intra-op to Post-op Ventilator/ Mechanical Support Use	12.83 hours Standard Deviation 19.12	11.62 hours Standard Deviation 60.38	13.30 hours Standard Deviation 77.73

SECONDARY outcome

Timeframe: Up to 48 hours after CPB

Initiation of Renal Replacement Therapy up to 48 Hours post CPB

Outcome measures

Outcome measures
Measure	CytoSorb Device n=56 Participants 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)	Control n=60 Participants 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)	Roll In: CytoSorb Device n=36 Participants 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)
Initiation of Renal Replacement Therapy	0 Participants	3 Participants	0 Participants

Adverse Events

CytoSorb Device

Serious events: 28 serious events

Other events: 35 other events

Deaths: 1 deaths

Control

Serious events: 21 serious events

Other events: 44 other events

Deaths: 1 deaths

Roll in: SOC + CytoSorb Device

Serious events: 14 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CytoSorb Device n=56 participants at risk 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)	Control n=60 participants at risk 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)	Roll in: SOC + CytoSorb Device n=36 participants at risk 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)
Cardiac disorders Atrial fibrillation	10.7% 6/56 • Number of events 7 • 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.	11.7% 7/60 • Number of events 7 • 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.	5.6% 2/36 • Number of events 2 • 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.
Cardiac disorders Atrioventricular block complete	8.9% 5/56 • Number of events 5 • 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.	1.7% 1/60 • Number of events 1 • 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.	5.6% 2/36 • Number of events 2 • 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.
Cardiac disorders Cardiogenic shock	3.6% 2/56 • Number of events 2 • 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.	5.0% 3/60 • Number of events 3 • 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.	2.8% 1/36 • Number of events 1 • 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.
Injury, poisoning and procedural complications Anaemia postoperative	12.5% 7/56 • Number of events 7 • 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.	5.0% 3/60 • Number of events 3 • 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.	5.6% 2/36 • Number of events 3 • 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.
Renal and urinary disorders Acute kidney injury	1.8% 1/56 • Number of events 1 • 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.	5.0% 3/60 • Number of events 3 • 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.	5.6% 2/36 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.4% 3/56 • Number of events 3 • 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.	3.3% 2/60 • Number of events 2 • 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.	2.8% 1/36 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.8% 1/56 • Number of events 1 • 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.	0.00% 0/60 • 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.	5.6% 2/36 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/56 • 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.	1.7% 1/60 • Number of events 1 • 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.	5.6% 2/36 • Number of events 2 • 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.
Vascular disorders Hypotension	5.4% 3/56 • Number of events 3 • 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.	1.7% 1/60 • Number of events 1 • 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.	0.00% 0/36 • 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.

Other adverse events

Additional Information

Darlene Lambert-Christie/ Director, Clinical Operations

Cytosorbents

Phone: 732.822.3332

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	CytoSorb Device n=56 participants at risk 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)	Control n=60 participants at risk 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)	Roll in: SOC + CytoSorb Device n=36 participants at risk 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)
Blood and lymphatic system disorders Leukocytosis	3.6% 2/56 • Number of events 2 • 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.	15.0% 9/60 • Number of events 9 • 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.	2.8% 1/36 • Number of events 1 • 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.
Blood and lymphatic system disorders Thrombocytopenia	17.9% 10/56 • Number of events 10 • 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.	11.7% 7/60 • Number of events 7 • 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.	27.8% 10/36 • Number of events 10 • 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.
Cardiac disorders Cardiogenic shock	0.00% 0/56 • 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.	1.7% 1/60 • Number of events 1 • 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.	8.3% 3/36 • Number of events 3 • 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.
Cardiac disorders Sinus bradycardia	0.00% 0/56 • 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.	0.00% 0/60 • 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.	5.6% 2/36 • Number of events 2 • 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.
Gastrointestinal disorders Ileus	1.8% 1/56 • Number of events 1 • 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.	5.0% 3/60 • Number of events 3 • 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.	2.8% 1/36 • Number of events 1 • 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.
Injury, poisoning and procedural complications Anaemia postoperative	17.9% 10/56 • Number of events 10 • 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.	10.0% 6/60 • Number of events 6 • 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.	25.0% 9/36 • Number of events 9 • 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.
Metabolism and nutrition disorders Fluid overload	0.00% 0/56 • 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.	1.7% 1/60 • Number of events 1 • 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.	5.6% 2/36 • Number of events 2 • 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.
Metabolism and nutrition disorders Hyperglycaemia	7.1% 4/56 • Number of events 4 • 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.	5.0% 3/60 • Number of events 3 • 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.	13.9% 5/36 • Number of events 5 • 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.
Metabolism and nutrition disorders Hypocalcaemia	1.8% 1/56 • Number of events 1 • 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.	3.3% 2/60 • Number of events 2 • 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.	5.6% 2/36 • Number of events 2 • 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.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/56 • 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.	0.00% 0/60 • 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.	5.6% 2/36 • Number of events 2 • 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.
Metabolism and nutrition disorders Hypokalaemia	3.6% 2/56 • Number of events 2 • 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.	1.7% 1/60 • Number of events 1 • 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.	8.3% 3/36 • Number of events 3 • 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.
Metabolism and nutrition disorders Hyponatraemia	3.6% 2/56 • Number of events 2 • 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.	0.00% 0/60 • 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.	5.6% 2/36 • Number of events 2 • 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.
Renal and urinary disorders Acute Kidney injury	1.8% 1/56 • Number of events 1 • 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.	3.3% 2/60 • Number of events 2 • 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.	8.3% 3/36 • Number of events 3 • 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.
Renal and urinary disorders Urinary retention	0.00% 0/56 • 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.	5.0% 3/60 • Number of events 3 • 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.	8.3% 3/36 • Number of events 3 • 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.
Renal and urinary disorders Acute respiratory failure	7.1% 4/56 • Number of events 4 • 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.	10.0% 6/60 • Number of events 6 • 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.	8.3% 3/36 • Number of events 3 • 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.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.4% 3/56 • Number of events 3 • 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.	3.3% 2/60 • Number of events 2 • 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.	2.8% 1/36 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/56 • 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.	1.7% 1/60 • Number of events 1 • 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.	5.6% 2/36 • Number of events 2 • 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.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.6% 2/56 • Number of events 2 • 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.	5.0% 3/60 • Number of events 3 • 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.	5.6% 2/36 • Number of events 2 • 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.