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Completed

NCT Number: NCT03484104

Cerebral Perfusion in 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.

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Key information

Conditions

Cerebrovascular Circulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, University Hospital Bern, University of Bern, Bern, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of tissue oxygenation index (TOI)

Diagnostic Test

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2018
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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