Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03144258
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil

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.

Condition or disease
Congenital Heart Disease

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Systemic Microcirculation in the Course of Cardiopulmonary Bypass Used in the Surgery for Repair of Congenital Heart Defects in Infants and Children
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Microcirculatory alterations during cardiopulmonary bypass [ Time Frame: december 2019 ]
    Evaluation of the alterations of microcirculatory parameters and tissue perfusion during cardiopulmonary bypass in children submitted to cardiac corrective surgery for congenital heart defects



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
infants and children with congenital heart defects scheduled to corrective cardiac surgery
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03144258


Contacts
Layout table for location contacts
Contact: Eduardo Tibirica, MD, PhD +55-21-99914-6075 etibi@uol.com.br
Contact: Viviana Ugenti, MD +55-21-99978-8684 vivugenti@gmail.com

Locations
Layout table for location information
Brazil
National Institute of Cardiology, Ministry of Health, Brazil Recruiting
Rio de Janeiro, Brazil, 22240-006
Contact: Eduardo V Tibirica, MD, PhD    +55-21-999146075    etibi@uol.com.br   
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
Layout table for investigator information
Principal Investigator: Eduardo Tibirica, MD, PhD National Institute of Cardiology

Layout table for additonal information
Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT03144258     History of Changes
Other Study ID Numbers: CAAE 19201413.6.0000.5272
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil:
congenital heart defects
systemic microcirculation
laser Doppler perfusion imaging
cardiac corrective surgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities