Clinical Trial: Clinical Assessment of Perfusion Techniques During Repair of Coarctation With Aortic Arch Hypoplasia in Infants

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Assessment of Perfusion Techniques During Surgical Repair of Coarctation of Aorta With Aortic Arch Hypoplasia in Infants

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 Summary: 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)
Sponsor: Meshalkin Research Institute of Pathology of Circulation

Current Primary Outcome: Adverse events in early postoperative period [ Time Frame: 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) )


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Degree of inotropic support (inotropic score) [ Time Frame: through ICU stay, an average of 3 weeks ]
  • Intraoperative blood loss (ml) [ Time Frame: intraoperatively ]
  • Temperature of cooling (C) [ Time Frame: intraoperatively ]
  • Duration of CPB (min) [ Time Frame: intraoperatively ]


Original Secondary Outcome: Same as current

Information By: Meshalkin Research Institute of Pathology of Circulation

Dates:
Date Received: July 6, 2016
Date Started: July 2016
Date Completion: August 2019
Last Updated: July 15, 2016
Last Verified: July 2016