Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: A Randomized Study
Information source: University Hospital, Ghent
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cerebral Oxygenation
Intervention: nitroprusside (Drug); nitroglycerine (Drug); sevoflurane (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Annelies Moerman, MD, Principal Investigator, Affiliation: University Hospital, Ghent
Overall contact:
Annelies Moerman, MD, Phone: 0032/(0)9/240.46.62, Email: annelies.moerman@ugent.be
Summary
In a prospective and randomized study protocol, three different blood pressure regulating
agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect
on the cerebral oxygen balance between both hemispheres during aortic coarctation repair.
Cerebral and somatic saturation will be monitored non-invasively and continuously via optical
sensors applied to the right and left forehead and the somatic regions. Arterial blood
pressure, central venous pressure, heart rate and systemic saturation will be recorded
continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6
definite time intervals. The study ends at the end of the operation.
Clinical Details
Official title: Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Cerebral saturation
Eligibility
Minimum age: N/A.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- All neonates and infants
- Aged 0-18 year
- With aortic coarctation requiring surgical correction without the additional use of
cardiopulmonary bypass will be included.
Exclusion Criteria:
- All patients with an associated cardiac effect are excluded.
Locations and Contacts
Annelies Moerman, MD, Phone: 0032/(0)9/240.46.62, Email: annelies.moerman@ugent.be
University Hospital Ghent, Ghent 9000, Belgium; Recruiting
Annelies Moerman, MD, Phone: 0032/(0)9/240.46.62, Email: annelies.moerman@ugent.be
Annelies Moerman, MD, Principal Investigator
Additional Information
Website of the University Hospital Ghent
Starting date: October 2007
Ending date: December 2010
Last updated: September 25, 2008
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