NCT02617602

Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children

Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

Goal directed therapy (GDT) utilises various monitoring techniques to assess cardiovascular performance and allows for timely interventions based on predetermined algorithms. The aim of this prospective randomised study is to evaluate the effect of GDT on major complications in children undergoing radical correction of congenital heart defects, complicated by acute heart failure. Goal directed therapy will be implemented with the aid of transpulmonary thermodilution and based on predetermined algorithms.

Conditions

• Cardiac Surgery

Interventions

Type	Name	Description
PROCEDURE	Goal directed therapy	Based on transpulmonary thermodilution data, the following interventions will be implemented: Global end diastolic volume (GEDV) ≤ 430 ml/m2 and extravascular water index (EVWI) ≤ 10 ml/kg: fluid load; GEDV ≥ 550 ml/m2 and EVWI ≥ 10 ml/kg: furosemide; cardiac index (CI) ≤ 2 l/min/m2 - inotropic support: * decreased heart rate (HR): dobutamine, dopamine; * normal or increased HR: epinephrine, norepinephrine; CI ≥ 2 l/min/m2 and normovolemia: phenylephrine.
OTHER	Control

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-11-01
• Completion: 2017-12-01
• First posted: 2015-12-01
• Last updated: 2015-12-18

Locations

1 site across 1 country: Russia