Cerebral Oxymetry at Elective Coronary and Valve Surgery.

Aortic Valve Regurgitation. Clinical Trial

— Co-HLM  

Official title:

Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940874
• Other study ID #: 2010/823
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: October 8, 2013
• Start date: February 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Ministry of Health and Care Services
• Study type: Observational

Clinical Trial Summary

Use of vasopressor to maintain Mean Arterial Pressure on Cardio Pulmonary Bypass can lead to decreased cerebral flow and oxygenation in individual patients and this can be detected by means of cerebral oxymetry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient age under 80.

• Patients should undergo elective coronary artery bypass grafting surgery (ACB) or heart valve surgery (AVR or MVR).

• The patient must be admitted at least 18 years of years.

Exclusion Criteria:

• Damage to the frontal lobes corresponding to the area where SCO2 monitored.

• Patients in pharmacological studies.

• Patients with known intracranial vascular anomalies or cerebral aneurysms.

• Patients with known neurological disease.

• Patients with known undergone cerebral insult, TIA or carotid stenosis.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aortic Valve Insufficiency
• Aortic Valve Regurgitation.
• Aortic Valve Stenosis
• Aortic Valve Stenosis.
• Coronary Artery Disease
• Coronary Artery Disease.
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxymetry values		March 2013	No