Cardiac; ArteriosclerosisNCT05620875
The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.
An observational study of Cardiac; Arteriosclerosis and Aortic Valve Disease, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac; Arteriosclerosis, Aortic Valve Disease
- What is being tested?
- Cerebral injury markers and Cerebral oximetry index
- How many people
- 106 participants
- Where
- 1 siteSweden
- Study dates
- 2 Jan 2023to 4 Jan 2025
- How long will I take part?
- 5 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 120 research subjects scheduled for coronary arterial bypass grafting surgery and/or aortic valve replacement in Uppsala University Hospital.
Who may be able to join
- Patients scheduled for CABG and/or AVR
Who cannot join
- Former diagnosed neurological insults, carotid stenosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cerebral injury markers, Cerebral oximetry index
- Medical subject headings
- Arteriosclerosis, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral injury markersDiagnostic test
Blood tests at given time points perioperatively.
Cerebral oximetry indexDiagnostic test
Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass | Not described Receives: Diagnostic Test: Cerebral injury markers; Diagnostic Test: Cerebral oximetry index | |
| Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass | Not described Receives: Diagnostic Test: Cerebral injury markers; Diagnostic Test: Cerebral oximetry index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start2 Jan 2023
- Primary completion4 Jan 2025
- Study completion4 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac; ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Karl-Henrik Grinnemo, Adj. Prof., Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620875
- Sponsor's protocol ID
- 2021-06630-01
- Status last verified
- May 2025
- First submitted
- 2 Nov 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Delivered Oxygen and Cerebral Impact During the Use of Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT05620875
- Acronym / sponsor ID
- 2021-06630-01
- Conditions
- Cardiac; Arteriosclerosis, Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass | – | Diagnostic Test: Cerebral injury markers, Diagnostic Test: Cerebral oximetry index |
| Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass | – | Diagnostic Test: Cerebral injury markers, Diagnostic Test: Cerebral oximetry index |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 120 research subjects scheduled for coronary arterial bypass grafting surgery and/or aortic valve replacement in Uppsala University Hospital.
Key inclusion criteria (1 listed)
- Patients scheduled for CABG and/or AVR
Key exclusion criteria (1 listed)
- Former diagnosed neurological insults, carotid stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral injury markersBlood tests at given time points perioperatively. | Diagnostic test | Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass, Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass |
| Cerebral oximetry indexCerebral oximetry index measurements with the aid of Near Infrared Spectroscopy | Diagnostic test | Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass, Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Henrik Grinnemo, Adj. Prof. principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac; Arteriosclerosis and Aortic Valve Disease, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COx (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.