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

Primary Purpose

Cardiac Surgery

Status
Unknown status
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Goal directed therapy
Control
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Surgery focused on measuring Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure

Eligibility Criteria

undefined - 3 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Novosibirsk Research Institute of Circulation PathologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Goal directed therapy

Control

Arm Description

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

Conventional therapy

Outcomes

Primary Outcome Measures

Major complications
Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis

Secondary Outcome Measures

Full Information

First Posted
November 23, 2015
Last Updated
December 17, 2015
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT02617602
Brief Title
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children
Official Title
Goal Directed Hemodynamic Management of Acute Heart Failure After Cardiac Surgery in Children: a Prospective Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
Keywords
Congenital heart defect, Cardiopulmonary bypass, Goal directed therapy, Acute heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Goal directed therapy
Arm Type
Experimental
Arm Description
Based on transpulmonary thermodilution, hemodynamic management will be implemented to achieve predefined goals
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional therapy
Intervention Type
Procedure
Intervention Name(s)
Goal directed therapy
Intervention Description
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
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
Major complications
Description
Composite of all-cause mortality, extracorporal membrane oxygenation use, cardiac arrest, renal impairment (pRIFLE score of "injury" or higher), sepsis
Time Frame
Through study completion, an average of 30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Lomivorotov, PhD
Phone
+79139164103
Email
vv_lomivorotov@meshalkin.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Dmitry Ponomarev, PhD
Phone
+79232339205
Email
d_ponomarev@meshalkin.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Lomivorotov, PhD
Organizational Affiliation
Novosibirsk Research Institute of Cirulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novosibirsk Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dmitry Ponomarev, PhD
Phone
+79232339205
Email
d_ponomarev@meshalkin.ru

12. IPD Sharing Statement

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

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