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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620875
• Other study ID #: 2021-06630-01
• Status: Recruiting
• Start date: January 2, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Uppsala University
• Contact: Henrik Arthursson, PhD student
• Phone: +46735247762
• Email: henrik.arthursson[@]surgsci.uu.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients scheduled for CABG and/or AVR

Exclusion Criteria:

• Former diagnosed neurological insults, carotid stenosis

Related Conditions & MeSH terms

• Aortic Valve Disease
• Arteriosclerosis

Intervention

Diagnostic Test:
• Cerebral injury markers
Blood tests at given time points perioperatively.
• Cerebral oximetry index
Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours
Primary	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.	96 hours