Evaluation of the Microcirculation During the Corrective... | NCT03144258

Studies
Evaluation of the Microcirculation During the Corrective Surgery of Congenital Heart Defects in Children

NCT03144258

Sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Status

Completed

Last Update Posted

Aug 21, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Congenital Heart Disease

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2018Actual

Primary Completion Date

Dec 30, 2018Actual

Completion Date

Dec 30, 2018Actual

First Submitted Date

May 4, 2017

First Submission Date that Met QC Criteria

May 5, 2017

First Posted Date

May 8, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2019

Last Update Posted Date

Aug 21, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Eduardo Tibirica, MD, PhD, Senior Researcher, National Institute of Cardiology, Laranjeiras, BrazilPrincipal Investigator

Lead Sponsor

National Institute of Cardiology, Laranjeiras, BrazilOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

General objective of the research project: To evaluate the alterations of systemic microvascular reactivity during cardiopulmonary bypass (CPB), in children submitted to cardiac surgery for repair of congenital heart defects.

Detailed Description

• Specific objectives:

To test the usefulness of skin laser Doppler flowmetry monitoring (LDPM) in the non-invasive evaluation of endothelium-dependent microvascular reactivity during CPB in children.
To investigate whether skin LDPM could be proposed as a clinical monitoring of tissue perfusion during CPB in pediatric cardiac surgery.
To investigate the effects of different anesthetic agents on microvascular reactivity during CPB.
To investigate the effects of cardiovascular and vasoactive drugs used during CPB on microvascular reactivity.
To evaluate the correlation of microcirculatory alterations observed during CPB with classical markers of tissue perfusion and oxygenation, including plasma lactate levels.
To evaluate the correlation of microcirculatory alterations observed during CPB with markers of systemic inflammation, including pro- and anti-inflammatory cytokines.
To evaluate the correlation of microcirculatory alterations observed during CPB with the plasma bioavailability of nitric oxide.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Microcirculatory alterations during cardiopulmonary bypass	Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects	december 2019

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants and children with congenital heart defects scheduled to corrective cardiac surgery

Exclusion Criteria:

age inferior to 3 months and superior to 6 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

6 Years

Standard Ages

Child

Study Population

infants and children with congenital heart defects scheduled to corrective cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eduardo Tibirica, MD, PhD	National Institute of Cardiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Cardiology, Ministry of Health, Brazil		Rio de Janeiro		22240-006	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided