Atrial and Brain Natriuretic Peptides in Bronchiolitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00347880
First received: July 3, 2006
Last updated: March 1, 2012
Last verified: March 2012
  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 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Atrial and Brain Natriuretic Peptides in Bronchiolitis

Resource links provided by NLM:


Further study details as provided by University of Florida:

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
Sampling Method:   Probability Sample
Study Population

Children between the ages of 37 weeks and 2 years old with evidence of bronchiolitis.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00347880     History of Changes
Other Study ID Numbers: IRB# 359-2004, GCRC 602
Study First Received: July 3, 2006
Last Updated: March 1, 2012
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

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

ClinicalTrials.gov processed this record on September 30, 2014