Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?

• ClinicalTrials.gov Identifier: NCT02672514
• Recruitment Status: Completed
• First Posted: February 3, 2016
• Results First Posted: March 27, 2017
• Last Update Posted: March 27, 2017
• Sponsor: Herzzentrum Coswig
• Information provided by (Responsible Party): PD Dr. Hausmann, Herzzentrum Coswig

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Acute Kidney Injury
• Interventions: Device: Minimally invasive extracorporeal circulation (MiECC); Device: Conventional extracorporeal circulation (CECC)
• Enrollment: 104

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	MiECC	CECC
Arm/Group Description	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.	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.
Period Title: Overall Study
Started	53	51
Completed	53	51
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Group B	Group A	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		53	51	104
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	51 participants	104 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	15 28.3%	12 23.5%	27 26.0%
	>=65 years	38 71.7%	39 76.5%	77 74.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	53 participants	51 participants	104 participants
		66.25 (8.95)	67.98 (8.43)	67.1 (9)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	53 participants	51 participants	104 participants
	Female	9 17.0%	7 13.7%	16 15.4%
	Male	44 83.0%	44 86.3%	88 84.6%

Outcome Measures

1. Primary Outcome

Title	Acute Kidney Injury
Description	[Not Specified]
Time Frame	within the first 30 days (plus or minus 3 days) after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group B	Group A
Arm/Group Description:	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.	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 Number of Participants Analyzed	53	51
Measure Type: Number; Unit of Measure: participants
direct after operation	7	41
1 hour after operation	9	40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The first blood samples from both groups were collected before cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.377
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups on arrival of intensive care unit.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.051
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples from both groups were collected 24 hours after Operation.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.282
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. These blood samples were collected 48 hours after cardiopulmonary Bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.277
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Creatinine concentration. We test the null hypothesis that serum Creatinine was the same in both groups. The blood samples were collected from both groups 72 hours after cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.308
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.211
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected on arrival of intensive care unit.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 24 hours after operation.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.221
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 48 hours after operation.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.796
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of serum Cystatin C concentration. We test the null hypothesis that serum Cystatin C was the same in both groups. The blood samples were collected 72 hours after operation.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.463
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The first blood samples were collected before cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.118
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected on arrival of intensive care unit.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected one hour after cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected four hours after cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0001
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Group B, Group A
	Comments	The early diagnosis of AKI currently depends on the detection of reduced kidney function by the rise of the postoperative NGAL levels in plasma. We test the null hypothesis that the NGAL level was the same in both groups. The blood samples were collected 48 hours after cardiopulmonary bypass.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.171
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	MiECC	CECC
Arm/Group Description	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.	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.
All-Cause Mortality
	MiECC	CECC
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	MiECC	CECC
	Affected / at Risk (%)	Affected / at Risk (%)
Total	12/53 (22.64%)	7/51 (13.73%)
Blood and lymphatic system disorders
dialysis † 1	1/53 (1.89%)	2/51 (3.92%)
Cardiac disorders
cardiogenic shock † 1	1/53 (1.89%)	1/51 (1.96%)
perioperative myocardial infarction † 1	1/53 (1.89%)	0/51 (0.00%)
pericardial effusion † 1	2/53 (3.77%)	0/51 (0.00%)
General disorders
reanimation † 1	1/53 (1.89%)	1/51 (1.96%)
Surgical and medical procedures
re-operation † 1	3/53 (5.66%)	2/51 (3.92%)
re-PTCA † 1	3/53 (5.66%)	1/51 (1.96%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (11.0)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	MiECC	CECC
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/53 (0.00%)	1/51 (1.96%)
Surgical and medical procedures
use of IABP † 1	0/53 (0.00%)	1/51 (1.96%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (11.0)

Limitations and Caveats

only a single-Center study; a small number of study participants.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Jessica Vogler
• Organization: Herzzentrum Coswig
• Phone: +491749740710
• EMail: j_vo@web.de

• Responsible Party: PD Dr. Hausmann, Herzzentrum Coswig
• ClinicalTrials.gov Identifier: NCT02672514
• Other Study ID Numbers: Rölig Studie
• First Submitted: January 19, 2016
• First Posted: February 3, 2016
• Results First Submitted: February 5, 2016
• Results First Posted: March 27, 2017
• Last Update Posted: March 27, 2017