Cerebral Perfusion in Hypothermic Circulatory Arrest

September 27, 2021 updated by: Gabor Erdös, University Hospital Inselspital, Berne

Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest

Selective antegrade cerebral perfusion (sACP) during aortic arch surgery in hypothermic circulatory arrest (HCA) is an established method for intraoperative neuroprotection. Although sACP is established as a beneficial method to reduce secondary neurological side effects due to brain-malperfusion, there are several parameters like sACP flow rate, perfusion pressure or temperature of the perfusate, where the optimal values remain unclear. The flow rate of the sACP-perfusate is increased according to center-specific standard-procedures. The optimal sACP flow rate, monitored by near infrared spectroscopy (NIRS), is to be investigated in this single center clinical prospective observational study. 40 Patients are enrolled over an estimated period of 14 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

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

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, University Hospital Bern, University of Bern
      • Bern, Switzerland, 3010
        • University of Bern

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult population scheduled for elective aortic arch surgery.

Description

Inclusion Criteria:

  • Age 18 years or older
  • Elective cardiac surgery with cardiopulmonary bypass
  • Hypothermic circulatory arrest
  • General informed consent signed

Exclusion Criteria:

- Severe stenotis in cerebral arteries

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypothermic circulatory arrest
Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion
Diagnostic test: Measurement of tissue oxygenation index (TOI)
TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest
Other Names:
  • Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TOI
Time Frame: through study completion, an average of 1 year
The primary outcome is the tissue oxygenation index (TOI: NIRS value) at sACP flow rates of 6 , 8 and 10 (ml/kg/min) in comparison to the TOI measured awake.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vmca
Time Frame: through study completion, an average of 1 year
The secondary outcome is the mean blood flow velocity in the middle cerebral artery at sACP the specified flow rates in comparison to the VmMCA during general anesthesia, after anesthesia induction.
through study completion, an average of 1 year
Neurologic accidents
Time Frame: through study completion, an average of 1 year
An additional secondary outcome measure are any neurologic accidents during the same hospital stay.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Principal Investigator: Gabor Erdoes, MD PhD, University of Bern

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)

July 1, 2018

Primary Completion (Actual)

September 28, 2021

Study Completion (Actual)

September 28, 2021

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 29, 2018

First Posted (Actual)

March 30, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-02216

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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