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Atrial and Brain Natriuretic Peptides in Bronchiolitis
This study has been completed.
First Received: July 3, 2006   Last Updated: January 9, 2009   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00347880
  Purpose

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.


Condition Phase
Bronchiolitis
Phase I

Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Atrial and Brain Natriuretic Peptides in Bronchiolitis

Further study details as provided by University of Florida:

Biospecimen Retention:   None Retained

Biospecimen Description:

Enrollment: 100
Study Start Date: September 2004
Study Completion Date: July 2007
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 fluid/diuretic 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 Children's 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.

  Eligibility

Ages Eligible for Study:   37 Weeks to 2 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • child between 37 weeks and 2 years old
  • chest X-ray evidence of peri-bronchial cuffing or air trapping
  • Two of the Following:
  • history or evidence of nasal secretion
  • inter-and/or sub-costal retractions
  • evidence of wheezing

Exclusion Criteria:

  • acute or chronic renal disease
  • chronic diuretic therapy
  • congenital cardiac disease
  • bronchopulmonary dysplasia
  • thyroid disease
  • pituitary abnormalities
  • history of reactive airway disease
  • asthma
  • cystic fibrosis
  • recent history of receiving steroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347880

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: K. Alex Daneshmand, D.O. University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida ( K. Alex Daneshmand )
Study ID Numbers: IRB# 359-2004, GCRC 602
Study First Received: July 3, 2006
Last Updated: January 9, 2009
ClinicalTrials.gov Identifier: NCT00347880     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Bronchiolitis
ANP
BNP
Atrial Natriuretic Peptide
Brain Natriuretic Peptide
Vasopressin
ADH
Pediatric
Respiratory Distress
Fluid Balance

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Arginine Vasopressin
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Bronchiolitis
Vasopressins
Bronchitis
Cardiovascular Agents

Additional relevant MeSH terms:
Natriuretic Peptide, Brain
Bronchial Diseases
Bronchiolitis
Physiological Effects of Drugs
Cardiovascular Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Natriuretic Agents
Lung Diseases
Therapeutic Uses
Bronchitis

ClinicalTrials.gov processed this record on May 07, 2009