Cerebral Oxymetry at Elective Coronary and Valve Surgery. (Co-HLM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01940874
First received: September 9, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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.


Condition
Coronary Artery Disease.
Aortic Valve Stenosis.
Aortic Valve Regurgitation.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxymetry at Elective Coronary and Valve Surgery: An Observational Study Using Norepinephrine to Maintain Arterial Blood Pressure on Cardio Pulmonary Bypass.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Cerebral oxymetry values [ Time Frame: March 2013 ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cerebral oximetry

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

We want to include 50 patients, both women and men, undergo elective coronary bypass surgery or valve surgeon in CPB with moderate hypothermia.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01940874

Locations
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Ove A. Hagen, MD Oslo Ùniversity Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01940874     History of Changes
Other Study ID Numbers: 2010/823
Study First Received: September 9, 2013
Last Updated: October 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Ministry of Health and Care Services

Keywords provided by Oslo University Hospital:
Cerebral Oximetry.
Aortic valve stenosis.
Aortic valve regurgitation.
Coronary artery disease.

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Aortic Valve Stenosis
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014