NCT05620875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 2, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2025

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

November 2, 2022

Last Update Submit

May 26, 2025

Conditions

Cardiac; ArteriosclerosisAortic Valve Disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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

Diagnostic Test: Cerebral injury markersDiagnostic Test: Cerebral oximetry index

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

Diagnostic Test: Cerebral injury markersDiagnostic Test: Cerebral oximetry index

Interventions

Cerebral injury markersDIAGNOSTIC_TEST

Blood tests at given time points perioperatively.

Group with DO2i <280 ml/min/m2 during cardiopulmonary bypassGroup with DO2i >280 ml/min/m2 during cardiopulmonary bypass
Cerebral oximetry indexDIAGNOSTIC_TEST

Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

120 research subjects scheduled for coronary arterial bypass grafting surgery and/or aortic valve replacement in Uppsala University Hospital.

You may qualify if:

  • Patients scheduled for CABG and/or AVR

You may not qualify if:

  • Former diagnosed neurological insults, carotid stenosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University Hospital

Uppsala, Uppsala County, 75135, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebral injury markers in blood plasma

MeSH Terms

Conditions

ArteriosclerosisAortic Valve Disease

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHeart Valve DiseasesHeart Diseases

Study Officials

  • Karl-Henrik Grinnemo, Adj. Prof.

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 17, 2022

Study Start

January 2, 2023

Primary Completion

January 4, 2025

Study Completion

January 4, 2025

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations

SE(1)