Trial Outcomes & Findings for Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting? (NCT NCT02672514)
NCT ID: NCT02672514
Last Updated: 2017-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
within the first 30 days (plus or minus 3 days) after surgery
Results posted on
2017-03-27
Participant Flow
Participant milestones
| Measure |
MiECC
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
|
CECC
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
51
|
|
Overall Study
COMPLETED
|
53
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
Baseline characteristics by cohort
| Measure |
Group B
n=53 Participants
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
|
Group A
n=51 Participants
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
38 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Continuous
|
66.25 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
67.98 years
STANDARD_DEVIATION 8.43 • n=7 Participants
|
67.1 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: within the first 30 days (plus or minus 3 days) after surgeryOutcome measures
| Measure |
Group B
n=53 Participants
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
|
Group A
n=51 Participants
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
|
|---|---|---|
|
Acute Kidney Injury
direct after operation
|
7 participants
|
41 participants
|
|
Acute Kidney Injury
1 hour after operation
|
9 participants
|
40 participants
|
Adverse Events
MiECC
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
CECC
Serious events: 7 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MiECC
n=53 participants at risk
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
|
CECC
n=51 participants at risk
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
|
|---|---|---|
|
Blood and lymphatic system disorders
dialysis
|
1.9%
1/53
|
3.9%
2/51
|
|
Cardiac disorders
cardiogenic shock
|
1.9%
1/53
|
2.0%
1/51
|
|
Cardiac disorders
perioperative myocardial infarction
|
1.9%
1/53
|
0.00%
0/51
|
|
Cardiac disorders
pericardial effusion
|
3.8%
2/53
|
0.00%
0/51
|
|
General disorders
reanimation
|
1.9%
1/53
|
2.0%
1/51
|
|
Surgical and medical procedures
re-operation
|
5.7%
3/53
|
3.9%
2/51
|
|
Surgical and medical procedures
re-PTCA
|
5.7%
3/53
|
2.0%
1/51
|
Other adverse events
| Measure |
MiECC
n=53 participants at risk
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.
Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
|
CECC
n=51 participants at risk
Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.
CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.
Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
|
|---|---|---|
|
Surgical and medical procedures
use of IABP
|
0.00%
0/53
|
2.0%
1/51
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place