Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Extracorporeal Circulation; Complications
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Renal oxygen delivery and blood flow
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
During open cardiac surgery, cardiopulmonary bypass (CPB) is used to temporarily replace the function of the heart and lungs. Renal ischemia resulting in acute kidney injury is common after cardiac surgery. The renal oxygenation is impaired during CPB, but the oxygenation may be improved by increasing the CPB blood flow. In this randomized study, two CPB flow rates will be compared regarding renal outcome (biomarkers and renal oxygenation/renal blood flow), as well as markers of inflammation and hemolysis. Additionally, urine oxygen tension will be measured during CPB and the early intensive care phase and compared to renal oxygenation. Regional oxygen saturation assessed with near infrared spectroscopy from the brain and kidneys will be monitored during and after surgery.
Investigators
Lukas Lannemyr
Specialist of Anesthesia and Intensive care
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
Inclusion Criteria
- •Written, signed informed consent
- •Male and female subjects ≥18 years
- •Left ventricular ejection fraction ≥30 %
- •Estimated GFR ≥30 ml/min using the CKD-EPI equation (Levey 2009)
- •Scheduled open cardiac surgery with CPB
- •Planned normothermia during CPB
- •Expected CPB time \> 60 minutes
Exclusion Criteria
- •Emergency surgery
- •Cardiac transplantation
- •Advanced grown-up congenital heart disease corrections
- •Previous cerebral infarction, verified with computed tomography or magnetic resonance imaging
- •Body mass index \> 32 kg/m2
- •Use of hypothermia \< 32 °C during CPB
- •Inability of the patient to give based opinion
- •In the investigator´s opinion, the patient has a condition that could be adversely affected by study participation
Outcomes
Primary Outcomes
Renal oxygen delivery and blood flow
Time Frame: 6 hours
Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
Biomarkers Nephrocheck
Time Frame: 24 hours
Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
Biomarker u-NAG
Time Frame: 24 hours
Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine.
Secondary Outcomes
- Serum creatinine and acute kidney injury (AKI)(48 hours)
- Inflammation IL-8(24 hours)
- Inflammation TNFa(24 hours)
- Inflammation IL-10(24 hours)
- Inflammation IL-1(24 hours)
- Inflammation IL-6(24 hours)
- Hemolysis(24 hours)
- Erythropoetin(24 hours)
- Neuroinflammation NF(4 days)
- Complement activation(24 hours)
- Kidney function(24 hours)
- Neuroinflammation Tau(4 days)
- Renal function(24 hours)