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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05620875
Enrollment
106
Registered
2022-11-17
Start date
2023-01-02
Completion date
2025-01-04
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Cardiac; Arteriosclerosis

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.

Interventions

DIAGNOSTIC_TESTCerebral injury markers

Blood tests at given time points perioperatively.

DIAGNOSTIC_TESTCerebral oximetry index

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Sponsors

Uppsala University Hospital
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients scheduled for CABG and/or AVR

Exclusion criteria

* Former diagnosed neurological insults, carotid stenosis

Design outcomes

Primary

MeasureTime frameDescription
COx24 hoursCOx (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, NSE96 hoursBrain injury markers that indicate cerebral neuronal damage on DO2 index values below set limits of 280 ml/m2/min.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026