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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Procedure: Goal directed therapy
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Goal directed therapy<br>Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals | Procedure: Goal directed therapy<br>* 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.<br>|
| Active Comparator: Control<br>Conventional therapy | Other: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major complications | Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of injury or higher), sepsis | Through study completion, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure