Effect of strategy for blood pressure control on cerebral oxygen balance during aortic coarctation repair: a randomized study
Phase 1
- Conditions
- aortic coarctation requiring surgical correctionMedDRA version: 9.1Level: LLTClassification code 10002894Term: Aortic coarctation
- Registration Number
- EUCTR2007-002640-19-BE
- Lead Sponsor
- niversity Hospital Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
All neonates and infants, aged 0 – 18 year, with aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
All patients with an associated cardiac defect
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: investigation of the effect of different blood pressure controlling agents on the cerebral oxygen balance between both brain hemispheres during aortic coarctation repair by using near-infrared technology;Secondary Objective: ;Primary end point(s): mean target blood pressure of 120 to 150 % of the blood pressure before clamping
- Secondary Outcome Measures
Name Time Method