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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02617602

Enrollment

Registered

2015-12-01

Start date

2015-12-31

Completion date

2017-12-31

Last updated

2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

Keywords

Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure

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.

Interventions

PROCEDUREGoal 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.

OTHERControl

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 3 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Russia

Contacts

Primary ContactVladimir Lomivorotov, PhD

vv_lomivorotov@meshalkin.ru+79139164103

Backup ContactDmitry Ponomarev, PhD

d_ponomarev@meshalkin.ru+79232339205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026