Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347880
Status:
COMPLETED
Last Update Posted:
2012-03-02
First Post:
2006-07-03
Brief Title:
Atrial and Brain Natriuretic Peptides in Bronchiolitis
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Atrial and Brain Natriuretic Peptides in Bronchiolitis
Status:
COMPLETED
Status Verified Date:
2012-03
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:
The purpose of this study is to collect information about what happens to certain chemicals produced in the body called hormones during respiratory infections such as bronchiolitis Bronchiolitis is an infection of small airways in the lungs caused by a virus This infection which causes swelling and injury in the lungs is commonly seen in infants and children less than 2 years of age
Detailed Description:
Intravascular volume and serum osmolality are tightly regulated by a balance of various neurohumoral mediators In critical illness these regulatory mediators may be modified by disease or treatment either benefiting or harming the patient Such regulatory mediators of intravascular volume and fluid balance include atrial natriuretic peptide ANP brain natriuretic peptide BNP and vasopressin also called antidiuretic hormone-ADH Although well studied in adult cardiac patients these neurohormones have not been investigated in pediatric respiratory diseases such as bronchiolitis a common cause of admission to the Pediatric Intensive Care Unit PICU Understanding the effects of pediatric respiratory diseases and treatment interventions on the concentrations of these neurohormonal regulators such as ANP and BNP is a crucial first step in formulating more effective fluid therapy For example some patients with bronchiolitis have elevated ADH levels Increased ADH concentration predisposes to fluid retention and increases the risk of pulmonary edema Since ANP and BNP antagonize the action of ADH simultaneous measurement of all three hormones may help elucidate the mechanisms of fluid balance in bronchiolitis
The study hypothesis is that the plasma concentrations of ANP and BNP in infants and children with bronchiolitis are inversely associated with ADH concentration and lung hyperinflation Furthermore plasma concentrations of ANP and BNP in bronchiolitis are associated directly with increased oxygen requirement and positive fluid balance The significance of this study is to better understand the relationship between various neurohormones that regulate intravascular fluid volume in patients with respiratory failure and bronchiolitis The understanding of this complex relationship has the potential to improve fluiddiuretic therapy and patient outcome with severe respiratory distress in the future
We plan to enroll 100 patients in this study The population will be infants and children between 37 weeks and 2 years of age corrected for gestational age 50 patients with bronchiolitis will be enrolled to collect ANP BNP and ADH plasma levels along with serum osmolality and urine osmolality for up to 5 consecutive days in Shands Childrens Hospital
Comparison 50 control patients will be enrolled to record normal baseline plasma ANP BNP and ADH at the time of admission in Shands Hospital surgical center at the University of Florida
The study hypothesis is that the plasma concentrations of ANP and BNP in infants and children with bronchiolitis are inversely associated with ADH concentration and lung hyperinflation Furthermore plasma concentrations of ANP and BNP in bronchiolitis are associated directly with increased oxygen requirement and positive fluid balance The significance of this study is to better understand the relationship between various neurohormones that regulate intravascular fluid volume in patients with respiratory failure and bronchiolitis The understanding of this complex relationship has the potential to improve fluiddiuretic therapy and patient outcome with severe respiratory distress in the future
We plan to enroll 100 patients in this study The population will be infants and children between 37 weeks and 2 years of age corrected for gestational age 50 patients with bronchiolitis will be enrolled to collect ANP BNP and ADH plasma levels along with serum osmolality and urine osmolality for up to 5 consecutive days in Shands Childrens Hospital
Comparison 50 control patients will be enrolled to record normal baseline plasma ANP BNP and ADH at the time of admission in Shands Hospital surgical center at the University of Florida
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GCRC 602 | None | None | None |