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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal CPB flow | No Intervention | In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.4 L/min/m2 throughout the CPB period. | |
| High CPB flow | Experimental | In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High CPB flow | Procedure | Target CPB flow 2.9 L/min/m2 throughout the CPB period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker u-NAG | Tubulus injury biomarker N-acetyl-ß-d-glucoseaminidase (NAG) will be analyzed in urine with a spectrophotometric method and corrected for urine creatinine. | 24 hours |
| Biomarkers Nephrocheck | Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine | 24 hours |
| Renal oxygen delivery and blood flow | Renal oxygen delivery during and after cardiopulmonary bypass (CPB) | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Serum creatinine and acute kidney injury (AKI) | Changes in serum creatinine | 48 hours |
| Inflammation IL-1 | Differences in inflammatory marker IL-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary pO2 | Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored. | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lukas Lannemyr | Gothenburg | Västra Götaland County | 416 53 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27906706 | Background | Lannemyr L, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of Cardiopulmonary Bypass on Renal Perfusion, Filtration, and Oxygenation in Patients Undergoing Cardiac Surgery. Anesthesiology. 2017 Feb;126(2):205-213. doi: 10.1097/ALN.0000000000001461. | |
| 30365961 | Result | Lannemyr L, Bragadottir G, Hjarpe A, Redfors B, Ricksten SE. Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation in Patients Undergoing Cardiac Operations. Ann Thorac Surg. 2019 Feb;107(2):505-511. doi: 10.1016/j.athoracsur.2018.08.085. Epub 2018 Oct 23. |
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To compare normal (2.4 L/min/m2) and high (2.9 L/min/m2) cardiopulmonary bypass flow during cardiac surgery
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| 24 hours |
| Inflammation IL-6 | Differences in inflammatory marker IL-6 | 24 hours |
| Inflammation IL-8 | Differences in inflammatory marker IL-8 | 24 hours |
| Inflammation IL-10 | Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa | 24 hours |
| Inflammation TNFa | Differences in inflammatory marker TNFa | 24 hours |
| Complement activation | Differences in complement activation | 24 hours |
| Hemolysis | Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin) | 24 hours |
| Erythropoetin | Differences in serum-erythropoietin | 24 hours |
| Neuroinflammation Tau | Changes in Tau | 4 days |
| Neuroinflammation NF | Changes Neurofilament | 4 days |
| Kidney function | Measured glomerular filtration rate (iohexol clearance) on postoperative day 1 | 24 hours |
| Renal function | Measured glomerular filtration rate by iohexole clearance on the first postoperative day | 24 hours |
| 28748536 | Result | Lannemyr L, Lundin E, Reinsfelt B, Bragadottir G, Redfors B, Oras J, Ricksten SE. Renal tubular injury during cardiopulmonary bypass as assessed by urinary release of N-acetyl-ss-D-glucosaminidase. Acta Anaesthesiol Scand. 2017 Oct;61(9):1075-1083. doi: 10.1111/aas.12946. Epub 2017 Jul 26. |
| 41838934 | Derived | Wijk J, Corderfeldt-Keiller A, Bragadottir G, Redfors B, Ricksten SE, Lannemyr L. Cardiopulmonary Bypass Flow Rate and the Kidney: Reply. Anesthesiology. 2026 May 1;144(5):1259-1260. doi: 10.1097/ALN.0000000000005957. Epub 2026 Mar 16. No abstract available. |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D006461 | Hemolysis |
| D020143 | Gangliosidoses, GM2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005733 | Gangliosidoses |
| D013106 | Sphingolipidoses |
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008064 | Lipidoses |
| D008052 | Lipid Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |
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