NCT05620875

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac; Arteriosclerosis
• Aortic Valve Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cerebral injury markers	Blood tests at given time points perioperatively.
DIAGNOSTIC_TEST	Cerebral oximetry index	Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Timeline

• Start date: 2023-01-02
• Primary completion: 2025-01-04
• Completion: 2025-01-04
• First posted: 2022-11-17
• Last updated: 2025-05-30

Locations

1 site across 1 country: Sweden