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

Uppsala University

Status: Completed

Conditions: Aortic Valve Disease; Cardiac; Arteriosclerosis

Treatments: Diagnostic Test: Cerebral oximetry index; Diagnostic Test: Cerebral injury markers

Study type: Observational

Funder types: Other

Identifiers

NCT05620875

2021-06630-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for CABG and/or AVR

Exclusion criteria

• Former diagnosed neurological insults, carotid stenosis

Trial design

106 participants in 2 patient groups

Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass

Treatment:

Diagnostic Test: Cerebral injury markers

Diagnostic Test: Cerebral oximetry index

Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass

Treatment:

Diagnostic Test: Cerebral injury markers

Diagnostic Test: Cerebral oximetry index