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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00238810
• Other study ID #: 05.068
• Status: Completed
• Phase: N/A
• First received: October 12, 2005
• Last updated: November 26, 2014
• Start date: April 2005
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Children's Healthcare of Atlanta
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Congenital heart defect

Exclusion Criteria:

• Patients without congenital heart defects

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

References & Publications (1)

Nakayama T. The genetic contribution of the natriuretic peptide system to cardiovascular diseases. Endocr J. 2005 Feb;52(1):11-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	9 years	No