Coarctation of Aorta
Conditions
Keywords
Congenital heart disease, Coarctation of aorta, Aortic arch hypoplasia, Cerebral selective antegrade perfusion, Double arterial cannulation
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)
Interventions
PROCEDURESurgical repair of coarctation of aorta
Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Degree of inotropic support (inotropic score) | through ICU stay, an average of 3 weeks |
| Intraoperative blood loss (ml) | intraoperatively |
| Temperature of cooling (C) | intraoperatively |
| Duration of CPB (min) | intraoperatively |
Countries
Russia
Contacts
Primary ContactYuriy Y Kulyabin, MD
Outcome results
None listed