An observational study in Cardiac; Arteriosclerosis and Aortic Valve Disease, sponsored by Uppsala University. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2025-05-30.
Sponsored by Uppsala University · Observational
Investigating the connection between delivered oxygen index and cerebral impact with COx (cerebral oximetry index) och cerebral injury markers during the routine use of cardiopulmonary bypass.
The research subjects are to be treated with CPB with according to local standards (perfusion index 2.4 x body surface area). While measuring impact on cerebral autoregulation with the aid of Near InfraRed Spectroscopy (NIRS) and brain injury markers in blood, research subjects depending on initial hemoglobin value, will divide into two subgroups: one with DO2I of >280 ml/min/m2, and one with DO2I of \<280 ml/min/m2.
DO2I will during CPB be calculated using the patient data monitoring system Metavision.
With a correlation analysis between NIRS and MAP (mean arterial pressure) a COx (Cerebral Oxymetry Index) r-value can indicate impact on cerebral autoregulation with values >0.3 - 0.5 during use of CPB 4.
Brain injury markers (Tau, Glial Fibrillary Acidic Protein (GFAP), Neurospecific Enolase (NSE)) are collected during 5 occasions during the first 24 hours and then once per day for 4 days, as well as markers for AKI (S-Creatinine) in some extent.
Registrations during the intensive care regarding delirium, stroke or other neurological impact will also be included in the study.
157 studies on the registry are indexed under Arteriosclerosis; 18 are open to participants now.
This study's enrollment of 106 is below the median of 280 across 46 observational studies indexed under Arteriosclerosis.
Browse Arteriosclerosis studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
120 research subjects scheduled for coronary arterial bypass grafting surgery and/or aortic valve replacement in Uppsala University Hospital.
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Exclusion Criteria:
Diagnostic Test: Cerebral injury markers · Diagnostic Test: Cerebral oximetry index
Diagnostic Test: Cerebral injury markers · Diagnostic Test: Cerebral oximetry index
Blood tests at given time points perioperatively.
Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy
COx
COx (Cerebral Oximetry Index; correlation between rSO2 values (INVOS) and mean artery pressure) that indicated impact on cerebral autoregulation on DO2 index values below set limits of 280 ml/m2/min.
Time frame: 24 hours
Brain injury markers; tau, GFAP, NSE
Brain injury markers that indicate cerebral neuronal damage on DO2 index values below set limits of 280 ml/m2/min.
Time frame: 96 hours
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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