Complication of Extracorporeal Circulation, Renal Impairment
Conditions
Brief summary
Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.
Detailed description
After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses
Interventions
PROCEDUREcardiopulmonary bypass
During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass
Sponsors
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Preserved left ventricular function (LVEF \> 50%) * Normal preoperative S-creatinine
Exclusion criteria
* Contraindications to radiocontrast * Cardiac transplantation och dissection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Blood Flow (RBF) | 6 hours | Renal blood flow measured with PAH clearance |
| Glomerular Filtration Rate (GFR) | 6 hours | GFR measured by renal extraction of 51Cr-EDTA |
| Renal Oxygenation | 6 hours | Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Excretion of NAG | 24 hours | Urinary biomarker of tubular renal injury |
| Development of Acute Kidney Injury (AKI) | 72 hours | AKI according to AKIN criteria |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CardioPulmonary Bypass Open cardiac surgery with normothermic Cardiopulmonary Bypass at 2.5 L/min/m2. | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | CardioPulmonary Bypass | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 13 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Left ventricular ejection fraction | 58 % STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Sweden | 18 participants | — |
| Serum creatinine | 87 micromol per litre STANDARD_DEVIATION 11 | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 4 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Glomerular Filtration Rate (GFR)
GFR measured by renal extraction of 51Cr-EDTA
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CardioPulmonaryBypass | Glomerular Filtration Rate (GFR) | Before CPB | 67 ml per minute per 1.73 m2 body surface | Standard Deviation 23 |
| CardioPulmonaryBypass | Glomerular Filtration Rate (GFR) | CPB 30 minutes | 68 ml per minute per 1.73 m2 body surface | Standard Deviation 23 |
| CardioPulmonaryBypass | Glomerular Filtration Rate (GFR) | CPB 60 minutes | 70 ml per minute per 1.73 m2 body surface | Standard Deviation 19 |
| CardioPulmonaryBypass | Glomerular Filtration Rate (GFR) | Post CPB (30 - 60 minutes) | 67 ml per minute per 1.73 m2 body surface | Standard Deviation 18 |
Comparison: Repeated measures ANOVAp-value: 0.972ANOVA
Primary
Renal Blood Flow (RBF)
Renal blood flow measured with PAH clearance
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CardioPulmonaryBypass | Renal Blood Flow (RBF) | Pre CPB | 554 ml per minute per 1.73 m2 body surface | Standard Deviation 126 |
| CardioPulmonaryBypass | Renal Blood Flow (RBF) | CPB 30 minutes | 524 ml per minute per 1.73 m2 body surface | Standard Deviation 116 |
| CardioPulmonaryBypass | Renal Blood Flow (RBF) | CPB 60 minutes | 564 ml per minute per 1.73 m2 body surface | Standard Deviation 162 |
| CardioPulmonaryBypass | Renal Blood Flow (RBF) | Post CPB (30 - 60 minutes) | 558 ml per minute per 1.73 m2 body surface | Standard Deviation 130 |
Comparison: Repeated measures ANOVA throughout measurement period (before, during and after CPB).p-value: 0.638ANOVA
Primary
Renal Oxygenation
Renal oxygen extraction, defined as renal oxygen consumption divided by renal oxygen delivery
Time frame: 6 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CardioPulmonaryBypass | Renal Oxygenation | Pre CPB | 0.09 fraction | Standard Deviation 0.03 |
| CardioPulmonaryBypass | Renal Oxygenation | CPB 30 minutes | 0.12 fraction | Standard Deviation 0.05 |
| CardioPulmonaryBypass | Renal Oxygenation | CPB 60 minutes | 0.13 fraction | Standard Deviation 0.06 |
| CardioPulmonaryBypass | Renal Oxygenation | Post CPB (30 - 60 minutes) | 0.16 fraction | Standard Deviation 0.05 |
Comparison: Repeated measures ANOVAp-value: <0.001ANOVA
Secondary
Development of Acute Kidney Injury (AKI)
AKI according to AKIN criteria
Time frame: 72 hours
Secondary
Excretion of NAG
Urinary biomarker of tubular renal injury
Time frame: 24 hours