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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 3

Conditions: Cardiac Surgery

Treatments: Procedure: Goal directed therapy; Other: Control

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02617602

GDT1.0

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 3 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Goal directed therapy

Experimental group

Description:

Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals

Treatment:

Procedure: Goal directed therapy

Control

Active Comparator group

Description:

Conventional therapy

Treatment:

Other: Control