Cerebral Perfusion in Hypothermic Circulatory Arrest

NCT ID: NCT03484104

Last Updated: 2021-09-29

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

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebrovascular Circulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hypothermic circulatory arrest

Patients undergoing cardiac surgery with hypothermic circulatory arrest and selective antegrade cerebral perfusion

Measurement of tissue oxygenation index (TOI)

Intervention Type DIAGNOSTIC_TEST

TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest

Interventions

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Measurement of tissue oxygenation index (TOI)

TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Measurement of mean blood flow velocity in the middle cerebral artery (Vmca)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Gabor Erdös

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gabor Erdoes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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Inselspital, University Hospital Bern, University of Bern

Bern, , Switzerland

Site Status

University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-02216

Identifier Type: -

Identifier Source: org_study_id

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