Cytokine Removal in Cardiopulmonary Bypass Patients (CytoSorb)

• ClinicalTrials.gov Identifier: NCT01879176
• Recruitment Status: Completed
• First Posted: June 17, 2013
• Results First Posted: January 10, 2017
• Last Update Posted: February 23, 2017
• Sponsor: Medical University of Vienna
• Collaborator: CytoSorbents, Inc
• Information provided by (Responsible Party): Dr. Martin Bernardi, Medical University of Vienna

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Elective Cardiac Surgical Interventions
• Intervention: Device: CytoSorb
• Enrollment: 46

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	CytoSorb	Control
Arm/Group Description	For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 . CytoSorb	No filter will be installed on the CPB machine.
Period Title: Overall Study
Started	24	22
Completed	16	16
Not Completed	8	6

Baseline Characteristics

Arm/Group Title		CytoSorb	Control	Total
Arm/Group Description		For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.	No filter will be installed on the CPB machine.	Total of all reporting groups
Overall Number of Baseline Participants		19	18	37
Baseline Analysis Population Description		Patients, who were allocated to treatment or control after randomization
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	19 participants	18 participants	37 participants
		64; (30 to 81)	69; (50 to 81)	67; (30 to 81)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	19 participants	18 participants	37 participants
	Female	7 36.8%	4 22.2%	11 29.7%
	Male	12 63.2%	14 77.8%	26 70.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Austria	Number Analyzed	19 participants	18 participants	37 participants
		19	18	37

Outcome Measures

1. Primary Outcome

Title	IL-6
Description	[Not Specified]
Time Frame	1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CytoSorb	Control
Arm/Group Description:	For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .	No filter will be installed on the CPB machine.
Overall Number of Participants Analyzed	16	16
Median (Inter-Quartile Range); Unit of Measure: pg/ml
Preoperative	0; (0 to 0)	0; (0 to 0)
Before CPB	0; (0 to 0)	0; (0 to 0)
After CPB	62.9; (10.8 to 98.7)	63.6; (41.2 to 154.9)
2 hours after CPB	120.8; (49.0 to 160.8)	118.7; (68.4 to 255.9)
24 hours after CPB	111.6; (53.7 to 253.5)	120.9; (68.0 to 198.5)
48 hours after CPB	89.0; (61.4 to 160.5)	67.7; (43.7 to 134.5)
120 hours after CPB	0.4; (0 to 8.3)	8.2; (0.8 to 19.4)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	CytoSorb	Control
Arm/Group Description	For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 . CytoSorb	No filter will be installed on the CPB machine.
All-Cause Mortality
	CytoSorb	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	CytoSorb	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/19 (0.00%)	0/18 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	CytoSorb	Control
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/19 (0.00%)	0/18 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Martin H. Bernardi
• Organization: Medical University of Vienna
• Phone: 004314040041090
• EMail: martin.bernardi@meduniwien.ac.at

Publications of Results:

Bernardi MH, Rinoesl H, Dragosits K, Ristl R, Hoffelner F, Opfermann P, Lamm C, Preissing F, Wiedemann D, Hiesmayr MJ, Spittler A. Effect of hemoadsorption during cardiopulmonary bypass surgery - a blinded, randomized, controlled pilot study using a novel adsorbent. Crit Care. 2016 Apr 9;20:96. doi: 10.1186/s13054-016-1270-0.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wisgrill L, Lamm C, Hell L, Thaler J, Berger A, Weiss R, Weber V, Rinoesl H, Hiesmayr MJ, Spittler A, Bernardi MH. Influence of hemoadsorption during cardiopulmonary bypass on blood vesicle count and function. J Transl Med. 2020 May 15;18(1):202. doi: 10.1186/s12967-020-02369-x.

• Responsible Party: Dr. Martin Bernardi, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT01879176
• Other Study ID Numbers: 1095/2013
• First Submitted: June 7, 2013
• First Posted: June 17, 2013
• Results First Submitted: April 30, 2016
• Results First Posted: January 10, 2017
• Last Update Posted: February 23, 2017