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

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country40 target enrollmentDecember 2015

ConditionsCardiac Surgery

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cardiac Surgery
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 40
Locations: 1
Primary Endpoint: Major complications
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

December 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•informed written consent signed by legal representative (parent or guardian)
•radical correction of congenital heart defect(s)
•use of cardiopulmonary bypass
•vasoactive-inotropic Score of 10 or greater during first 24 hours after surgery.

Exclusion Criteria

•confirmed intranatal infection;
•gestational age \< 37 weeks;
•inotropic support prior to surgery;
•acute renal or hepatic failure prior to surgery;
•participation in conflicting randomised controlled studies.

Outcomes

Primary Outcomes

Major complications

Time Frame: Through study completion, an average of 30 days

Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis