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

December 5, 2023 updated by: Uppsala University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden, 75135
        • Recruiting
        • Uppsala University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Patients scheduled for CABG and/or AVR

Exclusion Criteria:

  • Former diagnosed neurological insults, carotid stenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group with DO2i <280 ml/min/m2 during cardiopulmonary bypass
Diagnostic test: Cerebral injury markers
Blood tests at given time points perioperatively.
Diagnostic test: Cerebral oximetry index
Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy
Group with DO2i >280 ml/min/m2 during cardiopulmonary bypass
Diagnostic test: Cerebral injury markers
Blood tests at given time points perioperatively.
Diagnostic test: Cerebral oximetry index
Cerebral oximetry index measurements with the aid of Near Infrared Spectroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours
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.
96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Uppsala University Hospital

Investigators

  • Principal Investigator: Karl-Henrik Grinnemo, Adj. Prof., Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 2, 2022

First Submitted That Met QC Criteria

November 10, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-06630-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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