The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.

Recruiting

• Conditions: Aortic Valve Disease; Cardiac; Arteriosclerosis
• Interventions: Diagnostic Test: Cerebral injury markers; Diagnostic Test: Cerebral oximetry index

• Registration Number: NCT05620875
• Lead Sponsor: Uppsala University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-17
• Study Start: 2023-01-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-13
• Primary Completion: 2024-09
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients scheduled for CABG and/or AVR

Exclusion Criteria

• Former diagnosed neurological insults, carotid stenosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass	Cerebral injury markers	-
Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass	Cerebral oximetry index	-
Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass	Cerebral oximetry index	-
Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass	Cerebral injury markers	-

Primary Outcome Measures

Name	Time	Method
COx	24 hours	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.
Brain injury markers; tau, GFAP, NSE	96 hours	Brain injury markers that indicate cerebral neuronal damage on DO2 index values below set limits of 280 ml/m2/min.

Trial Locations

Locations (1)

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden