Cerebral Hemodynamics During Sustained Intra-operative Hypotension

Cerebral Autoregulation Clinical Trial

Official title:

Cerebral Hemodynamics During Sustained Intra-operative Hypotension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016648
• Other study ID #: W20_244#20.270
• Status: Recruiting
• Start date: August 7, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2021
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Nicholaas H. Sperna Weiland, MD PhD
• Phone: 0031205669111
• Email: n.h.spernaweiland[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Objective:

The objective of this study is to describe the physiology of the cerebral autoregulation over time during extreme low blood pressures (BP).

Study design:

This is a retrospective data collection study. During the Personalized External Aortic Root Support (PEARS) procedure extreme low blood pressures < 65 mmHg are medically induced. Hemodynamic and neurophysiologic data is for clinic purposes stored.

Study population:

All patients requiring a PEARS study at the Amsterdam University Medical Centers, location Amsterdam Medical Center (AMC).

Investigation:

Cerebral parameters during sustained low blood pressures are monitored with the transcranial doppler (TCD) for cerebral blood flow velocity (CBFV), near infrared spectroscopy (NIRS) for cerebral tissue oxygenation (rS02) and the electroencephalography (EEG) for the cerebral activity. Blood pressure waveforms are retrieved from an invasive arterial catheter. Besides, blood gasses during the low blood pressures and cardiac output, measured with a Schwan Ganz catheter are collected as well as electronic health records (EHR) (like age, gender and weight). All these devices are implemented as stated in the clinic protocol.

Main study parameters/endpoints:

The investigators will describe the cerebral autoregulation (CA) in several ways to retrieve a cut-off or lower limit of the CA where the regulation is either intact or impaired. First the static CA will be created with the mean arterial pressure (MAP) and mean cerebral blood flow (CBFm), second, the CA will be described with the mean flow velocity index (Mx, a method which calculates the correlation between the MAP and CBFm), COX (correlation between MAP and rS02) and with data of the EEG.

After retrieval of the cut off or lower limit, the CA below this point will be described over time to check for differences.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Planned for a PEARS procedure

• Informed consent should be given

Exclusion Criteria:

• No informed consent

Related Conditions & MeSH terms

• Cerebral Autoregulation
• Hypotension

Locations

Country	Name	City	State
Netherlands	AUMC	Amsterdam	Noord-holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral autoregulation	A mechanism in the brain influenced by the cerebral blood pressure and cerebral blood flow velocity	During the entire operation, about 4 hours.