Cerebral Perfusion in Hypothermic Circulatory Arrest

Cerebrovascular Circulation Clinical Trial

Official title:

Cerebral Perfusion During Cardiac Surgery With Hypothermic Circulatory Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484104
• Other study ID #: 2017-02216
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: September 28, 2021

Study information

• Verified date: September 2021
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2021
• Est. primary completion date: September 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Circulation
• Hypothermia

Intervention

Diagnostic Test:
• Measurement of tissue oxygenation index (TOI)
TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest

Locations

Country	Name	City	State
Switzerland	Inselspital, University Hospital Bern, University of Bern	Bern
Switzerland	University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOI	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	Vmca	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
Secondary	Neurologic accidents	An additional secondary outcome measure are any neurologic accidents during the same hospital stay.	through study completion, an average of 1 year