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Completed

NCT Number: NCT05620875

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

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.

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Key information

Conditions

Cardiac; Arteriosclerosis Aortic Valve Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hospital

Uppsala, Uppsala County, 75135, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for CABG and/or AVR

Exclusion criteria

  • Former diagnosed neurological insults, carotid stenosis

Treatment and study plan

Cerebral injury markers

Diagnostic Test

Blood tests at given time points perioperatively.

Cerebral oximetry index

Diagnostic Test

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Primary outcomes

  1. COx

    Time frame: 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.

  2. Brain injury markers; tau, GFAP, NSE

    Time frame: 96 hours

    Brain injury markers that indicate cerebral neuronal damage on DO2 index values below set limits of 280 ml/m2/min.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Uppsala University Hospital

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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