Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants
Not Applicable
- Conditions
- Coarctation of Aorta
- Interventions
- Procedure: Surgical repair of coarctation of aorta
- Registration Number
- NCT02835703
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
The purpose of this study is to evaluate safety and efficacy of three main perfusion methods in surgical repair of coarctation of aorta with aortic arch hypoplasia in infants.
- Detailed Description
Three perfusion techniques of visceral protection will be assessed - deep hypothermic circulatory arrest, selective antegrade cerebral perfusion and double arterial cannulation (perfusion of brachiocephalic artery with thoracic descending aorta by two arterial cannulas)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- coarctation with severe aortic arch hypoplasia (distal aortic arch z-score < -2)
- coarctation of aorta with septal defects
Exclusion Criteria
- coarctation with mild aortic arch hypoplasia (distal aortic arch z-score > -2)
- complex congenital heart diseases including aortic arch hypoplasia (e.g. transposition of great arteries, double oulet right ventricle, atrioventricular septal defect, Shone's complex)
- univentricular and duct-dependent heart defects
- aortic valve and/or mitral valve stenosis/hypoplasia (aortic valve or mitral valve z-score < -2.0)
- left ventricular dysfunction (left ventricle ejection fraction < 60%)
- congenital renal or central nervous system anomalies
- related infectious diseases
- prematurity (gestational age < 37 weeks)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Selective antegrade cerebral perfusion Surgical repair of coarctation of aorta Surgical repair of coarctation of aorta using selective antegrade cerebral perfusion Deep hypothermic arrest Surgical repair of coarctation of aorta Surgical repair of coarctation of aorta under deep hypothermic circulatory arrest Double arterial cannulation Surgical repair of coarctation of aorta Surgical repair of coarctation of aorta using cerebral antegrade perfusion with descending aortic cannulation
- Primary Outcome Measures
Name Time Method Adverse events in early postoperative period 30 days after surgery Number of participants with adverse events that are related to treatment (including hospital mortality, renal injury (pRIFLE criteria), neurological complications (confirmed by CT or MRI) )
- Secondary Outcome Measures
Name Time Method Temperature of cooling (C) intraoperatively Duration of CPB (min) intraoperatively Degree of inotropic support (inotropic score) through ICU stay, an average of 3 weeks Intraoperative blood loss (ml) intraoperatively
Trial Locations
- Locations (1)
State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
🇷🇺Novosibirsk, Russian Federation