Clinical trial NCT00238810: Relationship of Brain Natriuretic Peptide (BNP) Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome
Official title: Retrospective Evaluation of Serum B-type Natriuretic Peptide Hormone Levels in Post-operative Patients and the Relationship of BNP Levels to Cardiac Diagnosis, Operation Performed, Post-operative Course and Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: BNP
Pediatrics
Congenital heart disease
b-type natriuretic peptide
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-10-14
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with congenital heart defects

Brief summary: 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: 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)

Eligibility criteria: Inclusion Criteria:

* Congenital heart defect

Exclusion Criteria:

* Patients without congenital heart defects

Primary outcomes:
measure: 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.
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University Cardiac Fellow at Children's Healthcare of Atlanta
name: Alecia Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.