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

NCT02617602 — Phase 3, Unknown, 40 participants, Meshalkin Research Institute of Pathology of Circulation
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Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial

RegistryNCT02617602
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment40 (Estimated)
SponsorMeshalkin Research Institute of Pathology of Circulation (Network)
ConditionsCardiac Surgery
InterventionsGoal directed therapy, Control (Procedure, other)
Datesstart 2015-12-01, primary completion 2017-11-01 (estimated), completion 2017-12-01 (estimated), first posted 2015-12-01, last updated 2015-12-18
Locations1 site in Russia

Related Papers Related Patents Related Grants Related Experts
All trials for Cardiac Surgery All trials of Goal directed therapy All trials of Control

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Goal directed therapyExperimentalProcedure: Goal directed therapyBased on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals
ControlActive comparatorOther: ControlConventional therapy
  • Goal directed therapy (Procedure): 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.
  • Control (Other)

+Outcome measures

Primary outcomes

  • 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

+Eligibility

Sex: All, ages: any to 3 Years

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.

+Locations (1)

FacilityCityCountryStatus
Novosibirsk Research Institute of Circulation PathologyNovosibirskRussiaRecruiting

+Investigators