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

NCT ID: NCT05620875

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-01-04

Brief Summary

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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

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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

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Cardiac; Arteriosclerosis Aortic Valve Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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

Cerebral injury markers

Intervention Type DIAGNOSTIC_TEST

Blood tests at given time points perioperatively.

Cerebral oximetry index

Intervention Type DIAGNOSTIC_TEST

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

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

Cerebral injury markers

Intervention Type DIAGNOSTIC_TEST

Blood tests at given time points perioperatively.

Cerebral oximetry index

Intervention Type DIAGNOSTIC_TEST

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Interventions

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Cerebral injury markers

Blood tests at given time points perioperatively.

Intervention Type DIAGNOSTIC_TEST

Cerebral oximetry index

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for CABG and/or AVR

Exclusion Criteria

* Former diagnosed neurological insults, carotid stenosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University Hospital

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl-Henrik Grinnemo, Adj. Prof.

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Uppsala University Hospital

Uppsala, Uppsala County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2021-06630-01

Identifier Type: -

Identifier Source: org_study_id

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