Relationship of Brain Natriuretic Peptide (BNP) Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome

NCT ID: NCT00238810

Last Updated: 2014-12-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess brain natriuretic peptide levels to evaluate the relationship of those levels with the diagnosis of congenital cardiac disease, operation performed, post-operative course, and outcome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Three types of natriuretic peptides (NP) have been isolated: atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), and C-type natriuretic peptide (CNP). The NP family elicits a number of vascular, renal and endocrine effects that help to maintain blood pressure and extracellular fluid volume. These effects are mediated by the specific binding of NP to cell surface receptors that have been characterized, purified and cloned from cells of the vasculature, kidney, adrenal gland and brain. There are 3 subtypes of NP receptors: type A natriuretic peptide receptor (NPRA), type B natriuretic peptide receptor (NPRB), and type C natriuretic peptide receptor (NPRC). All 3 subtypes affect cellular second messenger activity. The literature currently does not define the levels of b-type natriuretic peptide (BNP) in children with congenital heart disease undergoing surgery.

The investigator wishes to perform a retrospective chart review to define BNP levels in the pediatric cardiac defect population and to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome. The investigator will collect the following information from the medical record:

* Laboratory: BNP levels, serum pH, lactic acid, Co-ox, CBC, Chemistry
* Diagnosis
* Surgical Procedure
* Incidence of re-operation
* Length of ICU Stay
* Length of Hospital Stay
* Complications
* Length of Ventilation (how many days on the ventilator)
* Medications
* Cross Clamp Time
* Bypass Time
* Echocardiogram data
* Cardiac Catheterization Data
* Vital Signs
* Monitored Hemodynamic Measures
* Final outcome (discharged or death)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Congenital Heart Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Congenital heart defect

Exclusion Criteria

* Patients without congenital heart defects
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alecia Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University Cardiac Fellow at Children's Healthcare of Atlanta

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Nakayama T. The genetic contribution of the natriuretic peptide system to cardiovascular diseases. Endocr J. 2005 Feb;52(1):11-21. doi: 10.1507/endocrj.52.11.

Reference Type BACKGROUND
PMID: 15758553 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05.068

Identifier Type: -

Identifier Source: org_study_id