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

Phase 3

• Conditions: Cardiac Surgery
• Interventions: Procedure: Goal directed therapy; Other: Control

• Registration Number: NCT02617602
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Posted: 2015-12-01
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18
• Primary Completion: 2017-11
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal directed therapy	Goal directed therapy	Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals
Control	Control	Conventional therapy

Primary Outcome Measures

Name	Time	Method
Major complications	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

Trial Locations

Locations (1)

Novosibirsk Research Institute of Circulation Pathology; 🇷🇺 Novosibirsk, Russian Federation