Trial Outcomes & Findings for Cytokine Removal in Cardiopulmonary Bypass Patients (NCT NCT01879176)
NCT ID: NCT01879176
Last Updated: 2017-02-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours
Results posted on
2017-02-23
Participant Flow
Participant milestones
| Measure |
CytoSorb
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
|
Control
No filter will be installed on the CPB machine.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
22
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cytokine Removal in Cardiopulmonary Bypass Patients
Baseline characteristics by cohort
| Measure |
CytoSorb
n=19 Participants
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.
|
Control
n=18 Participants
No filter will be installed on the CPB machine.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
69 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Gender
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Gender
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=5 Participants
|
18 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hoursOutcome measures
| Measure |
CytoSorb
n=16 Participants
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 .
|
Control
n=16 Participants
No filter will be installed on the CPB machine.
|
|---|---|---|
|
IL-6
Preoperative
|
0 pg/ml
Interval 0.0 to 0.0
|
0 pg/ml
Interval 0.0 to 0.0
|
|
IL-6
Before CPB
|
0 pg/ml
Interval 0.0 to 0.0
|
0 pg/ml
Interval 0.0 to 0.0
|
|
IL-6
After CPB
|
62.9 pg/ml
Interval 10.8 to 98.7
|
63.6 pg/ml
Interval 41.2 to 154.9
|
|
IL-6
2 hours after CPB
|
120.8 pg/ml
Interval 49.0 to 160.8
|
118.7 pg/ml
Interval 68.4 to 255.9
|
|
IL-6
24 hours after CPB
|
111.6 pg/ml
Interval 53.7 to 253.5
|
120.9 pg/ml
Interval 68.0 to 198.5
|
|
IL-6
48 hours after CPB
|
89.0 pg/ml
Interval 61.4 to 160.5
|
67.7 pg/ml
Interval 43.7 to 134.5
|
|
IL-6
120 hours after CPB
|
0.4 pg/ml
Interval 0.0 to 8.3
|
8.2 pg/ml
Interval 0.8 to 19.4
|
Adverse Events
CytoSorb
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place