Acute Kidney Injury
Conditions
Brief summary
The aim of this study was to prospectively evaluate MECC compared with conventional extracorporeal circulation of diabetic patients undergoing elective coronary revascularization procedures. The investigators focused on the effects of extracorporeal circulation especially the renal function between both groups.
Detailed description
Cardiopulmonary bypass (CPB) is known having a negative influence referring to systemic inflammatory reaction after cardiac surgery which can cause acute kidney injury (AKI). Miniaturized extracorporeal circulation (MECC) attempts to reduce the adverse effects of conventional extracorporeal circulation bypass. Finally, AKI after CPB is a significant clinical problem that increasingly complicates the course of hospitalization and clinical outcome.
Interventions
DEVICEMinimally invasive extracorporeal circulation (MiECC)
Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
Sponsors
Herzzentrum Coswig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetes mellitus type 2 * isolated elective coronary revascularization
Exclusion criteria
* urgent or emergent Status * Re-Operation * preexisting reanimation * preexisting renal transplantation * chronic kidney insufficiency (GFR \< 30 ml/min) * renal cell carcinoma * renal artery Stenosis * heart valve disease (middle- and high-grade) * endocarditis * infections (HIV, Tbc and all types of Hepatitis) * hepatic cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Kidney Injury | within the first 30 days (plus or minus 3 days) after surgery |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group B 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. | 53 |
| Group A 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. | 51 |
| Total | 104 |
Baseline characteristics
| Characteristic | Group A | Total | Group B |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 77 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 27 Participants | 15 Participants |
| Age, Continuous | 67.98 years STANDARD_DEVIATION 8.43 | 67.1 years STANDARD_DEVIATION 9 | 66.25 years STANDARD_DEVIATION 8.95 |
| Sex: Female, Male Female | 7 Participants | 16 Participants | 9 Participants |
| Sex: Female, Male Male | 44 Participants | 88 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 53 | 1 / 51 |
| serious Total, serious adverse events | 12 / 53 | 7 / 51 |
Outcome results
Primary
Acute Kidney Injury
Time frame: within the first 30 days (plus or minus 3 days) after surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group B | Acute Kidney Injury | direct after operation | 7 participants |
| Group B | Acute Kidney Injury | 1 hour after operation | 9 participants |
| Group A | Acute Kidney Injury | direct after operation | 41 participants |
| Group A | Acute Kidney Injury | 1 hour after operation | 40 participants |
Comparison: 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.p-value: 0.377Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.051Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.282Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.277Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.308Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.211Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.004Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.221Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.796Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.463Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.118Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.0001Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.0001Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.0001Wilcoxon (Mann-Whitney)
Comparison: 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.p-value: 0.171Wilcoxon (Mann-Whitney)