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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02617602
• Other study ID #: GDT1.0
• Status: Recruiting
• Phase: Phase 3
• First received: November 23, 2015
• Last updated: December 17, 2015
• Start date: December 2015
• Est. completion date: December 2017

Study information

• Verified date: December 2015
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Vladimir Lomivorotov, PhD
• Phone: +79139164103
• Email: vv_lomivorotov[@]meshalkin.ru
• Is FDA regulated: No
• Health authority: Russian Federation: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Circulation Pathology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No