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

NCT02617602 | Unknown Phase 3

• 1 other identifier: GDT1.0
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Surgery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Goal directed therapy

EXPERIMENTAL

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

Procedure: Goal directed therapy

Control

ACTIVE COMPARATOR

Conventional therapy

Other: Control

Interventions

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.

Goal directed therapy

Control OTHER

Control

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Novosibirsk Research Institute of Circulation Pathology

Novosibirsk, 630055, Russia

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Early Goal-Directed Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Critical Care; Patient Care; Therapeutics

Study Officials

• Vladimir Lomivorotov, PhD

  Novosibirsk Research Institute of Cirulation Pathology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Lomivorotov, PhD

CONTACT

+79139164103; vv_lomivorotov@meshalkin.ru

Dmitry Ponomarev, PhD

CONTACT

+79232339205; d_ponomarev@meshalkin.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 1, 2015
• Study Start: December 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

RU (1)