| Registry | NCT04084301, acronym ICAROX2 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, prevention |
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| Enrollment | 100 (Actual) |
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| Sponsor | Sahlgrenska University Hospital (Other) |
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| Conditions | Extracorporeal Circulation; Complications, Renal Failure, Circulation Disorder, Renal Plasma Flow, Effective, Cardiopulmonary Bypass, Hemolysis, Inflammatory Response |
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| Interventions | High CPB flow (Procedure) |
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| Dates | start 2019-09-27, primary completion 2023-11-01, completion 2023-11-01, first posted 2019-09-10, last updated 2023-11-22 |
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| Locations | 1 site in Sweden |
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Related Papers Related Patents Related Grants Related Experts
All trials for Extracorporeal Circulation; Complications All trials for Renal Failure All trials of High CPB flow
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| 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 | Procedure: High CPB flow | In this group, the target flow during cardiopulmonary bypass (CPB) will be 2.9 L/min/m2 throughout the CPB period. |
- High CPB flow (Procedure): Target CPB flow 2.9 L/min/m2 throughout the CPB period
+Outcome measures
Primary outcomes
- Biomarker u-NAG [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.
- Biomarkers Nephrocheck [24 hours]: Renal biomarker assay Nephrocheck (IGFBP-7 x TIMP-2) will be analyzed in urine
- Renal oxygen delivery and blood flow [6 hours]: Renal oxygen delivery during and after cardiopulmonary bypass (CPB)
Secondary outcomes
- Serum creatinine and acute kidney injury (AKI) [48 hours]: Changes in serum creatinine
- Inflammation IL-1 [24 hours]: Differences in inflammatory marker IL-1
- Inflammation IL-6 [24 hours]: Differences in inflammatory marker IL-6
- Inflammation IL-8 [24 hours]: Differences in inflammatory marker IL-8
- Inflammation IL-10 [24 hours]: Differences in inflammatory markers IL-1, IL-6, IL-8, IL-10 and TNFa
- Inflammation TNFa [24 hours]: Differences in inflammatory marker TNFa
- Complement activation [24 hours]: Differences in complement activation
- Hemolysis [24 hours]: Differences in markers of hemolysis (free plasma Hb, LD, haptoglobin)
- Erythropoetin [24 hours]: Differences in serum-erythropoietin
- Neuroinflammation Tau [4 days]: Changes in Tau
- Neuroinflammation NF [4 days]: Changes Neurofilament
- Kidney function [24 hours]: Measured glomerular filtration rate (iohexol clearance) on postoperative day 1
- Renal function [24 hours]: Measured glomerular filtration rate by iohexole clearance on the first postoperative day
Other outcomes
- Urinary pO2 [24 hours]: Changes in urinary pO2 measured with laser doppler technique. Correlation with global renal oxygenation will be explored.
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Lukas Lannemyr | Gothenburg, Västra Götaland County | Sweden | |
+Publications
- 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. PMID 27906706
- Results publication: 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. PMID 30365961
- Results publication: 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. PMID 28748536
- Results publication: 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. PMID 41838934