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

NCT ID: NCT02617602

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Cardiac Surgery

Keywords

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Congenital heart defect Cardiopulmonary bypass Goal directed therapy Acute heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goal directed therapy

Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals

Group Type EXPERIMENTAL

Goal directed therapy

Intervention Type 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

Conventional therapy

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Interventions

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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.

Intervention Type PROCEDURE

Control

Intervention Type OTHER

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.
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vladimir Lomivorotov, PhD

Role: PRINCIPAL_INVESTIGATOR

Novosibirsk Research Institute of Cirulation Pathology

Locations

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Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Vladimir Lomivorotov, PhD

Role: CONTACT

Phone: +79139164103

Email: [email protected]

Dmitry Ponomarev, PhD

Role: CONTACT

Phone: +79232339205

Email: [email protected]

Facility Contacts

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Dmitry Ponomarev, PhD

Role: primary

Other Identifiers

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GDT1.0

Identifier Type: -

Identifier Source: org_study_id