Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330811
Status:
COMPLETED
Last Update Posted:
2016-12-02
First Post:
2006-05-25
Brief Title:
B-type Natriuretic Peptide in the Non-Cardiac Pediatric Patient
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
B-type Natriuretic Peptide in the Non-Cardiac Pediatric Patient
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
B-type Natriuretic Peptide BNP is a hormone that is made by the pumping chambers of the heart The BNP level can be measured by a blood test and is used as a marker for heart problems in adults Deciding if a child has a heart problem or a lung problem can be very difficult especially in infants Several studies have demonstrated that BNP levels are elevated when children have heart disease
The overall goal of the study is to be able to prove that obtaining BNP levels in pediatric patients can be used to identify heart problems We already know that kids with heart problems have high BNP levels 200pgml We need to prove that children who come to the Emergency Department for non-cardiac problems still have normal BNP levels 100pgml slightly higher in the newborn population This will be done by comparing BNP levels with the final diagnosis made by the ED physician
The overall goal of the study is to be able to prove that obtaining BNP levels in pediatric patients can be used to identify heart problems We already know that kids with heart problems have high BNP levels 200pgml We need to prove that children who come to the Emergency Department for non-cardiac problems still have normal BNP levels 100pgml slightly higher in the newborn population This will be done by comparing BNP levels with the final diagnosis made by the ED physician
Detailed Description:
Introduction At Childrens Healthcare of Atlanta thousands of children are seen in the Emergency Department ED each year for evaluation and treatment Deciding if a child has a cardiac or pulmonary problem can be very difficult especially in infants Early recognition of cardiac disease can significantly impact the physicians ability to provide appropriate treatment make necessary interventions and affect patient outcome An accurate laboratory marker of cardiac disease for pediatric Emergency Medicine does not exist B-Type Natriuretic Peptide BNP is a hormone produced by the ventricular myocardium heart muscle in response to increased myocardial demands It has been used extensively in the adult population to evaluate patients for heart disease and has been demonstrated to be very accurate in the differentiation of heart disease from lung disease in the adult Emergency Department
There is increasing experience with BNP in pediatrics for the evaluation of heart disease primarily in patients with congenital heart disease The normal BNP level is less than 100 pgml slightly higher in neonates Patients who present to the ED and are diagnosed with heart disease are often admitted to the Cardiac Intensive Care Unit CICU for further management and stabilization Part of the initial evaluation is a BNP level These patients usually have marked elevation of the BNP levels in the 2000-5000 pgml range upon admission The level varies with the type and severity of their heart disease However very little is known about the non-cardiac ED patient BNP level To utilize BNP as an accurate marker of cardiac disease in the pediatric ED a clear difference between cardiac and non-cardiac patients needs to be demonstrated If a large difference in BNP levels exists for the pediatric patient with heart disease who presents to the ED when compared to the child who presents to the ED with other non-cardiac disease processes a useful marker of heart disease in children would be demonstrated
Objectives The objective of the proposed research is to determine the typical BNP level in non-cardiac pediatric patients who present to the ED for evaluation of respiratory and or infectious processes The endpoint of the project will be the collection of BNP levels from 100 patients less than 6 years of age
Hypothesis 1 H1 BNP levels for children with non-cardiac disease will be in the normal range 100pgml and can be easily distinguished from the elevated levels seen in children with congenital or acquired heart disease
There is increasing experience with BNP in pediatrics for the evaluation of heart disease primarily in patients with congenital heart disease The normal BNP level is less than 100 pgml slightly higher in neonates Patients who present to the ED and are diagnosed with heart disease are often admitted to the Cardiac Intensive Care Unit CICU for further management and stabilization Part of the initial evaluation is a BNP level These patients usually have marked elevation of the BNP levels in the 2000-5000 pgml range upon admission The level varies with the type and severity of their heart disease However very little is known about the non-cardiac ED patient BNP level To utilize BNP as an accurate marker of cardiac disease in the pediatric ED a clear difference between cardiac and non-cardiac patients needs to be demonstrated If a large difference in BNP levels exists for the pediatric patient with heart disease who presents to the ED when compared to the child who presents to the ED with other non-cardiac disease processes a useful marker of heart disease in children would be demonstrated
Objectives The objective of the proposed research is to determine the typical BNP level in non-cardiac pediatric patients who present to the ED for evaluation of respiratory and or infectious processes The endpoint of the project will be the collection of BNP levels from 100 patients less than 6 years of age
Hypothesis 1 H1 BNP levels for children with non-cardiac disease will be in the normal range 100pgml and can be easily distinguished from the elevated levels seen in children with congenital or acquired heart disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None