Pepsin As A Biomarker For Aspiration

Sponsor
Medical College of Wisconsin (Other)
Overall Status
Completed
CT.gov ID
NCT00865995
Collaborator
(none)
76
1
58
1.3

Study Details

Study Description

Brief Summary

Evaluation of tracheal pepsin as a biomarker for aspiration

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tracheal Lavage

Detailed Description

Aspiration is well recognized in children who have chronic lung disease or who are intubated. There is a known association between gastroesophageal reflux (GER) and aspiration. The distinction between aspiration of swallowed material, such as food and the aspiration of refluxed gastric contents is important. Determining whether an aspiration syndrome in an individual is due to GER may be difficult. The most widely used test to determine whether GER is the cause of aspiration involves staining bronchoalveolar lavage (BAL) fluid for lipid laden macrophages (LLM) based on the hypothesis that refluxed and aspirated fluid is phagocytosed by tracheal macrophages.

Pepsinogen is a protein unique to gastric chief cells and also requires acidic conditions for activation. Therefore the presence of pepsin in BAL fluid should only be found when gastric fluid is aspirated. In previous studies, pepsin has been detected in the tracheal fluid of children with chronic lung disease. Thus far, studies of this material have been small, not all have control groups, and LLM were not looked for in all studies.

Based on previous studies and the need to improve diagnostic methods, the following aims are proposed:

  1. to determine the frequency of pepsin contamination of children without chronic respiratory disease undergoing elective surgery with intubation

  2. to determine frequency of tracheal pepsin and lipid laden macrophages (LLM) in children with chronic respiratory disease or symptoms and in children with tracheostomies

  3. to compare the presence or absence and concentration of pepsin to the presence of LLM

  4. to relate the presence or absence and concentration of pepsin to clinical status To achieve these aims, BAL fluid will be obtained from subject patients and controls. These fluids will be transported to the research lab and stored on ice until analysis. Determination of LLM will be done in children undergoing diagnostic bronchoscopy in the clinical lab of CHW per routine. BAL analysis will consist of Western blot staining for the presence of pepsin. Demographic data will also be collected from the medical record.

Study Design

Study Type:
Observational
Actual Enrollment :
76 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
1

patients undergoing elective procedures with intubation and no known respiratory pathology

Procedure: Tracheal Lavage
Tracheal Lavage will be performed on the control population patients and the tracheal fluid obtained from this procedure will be used as the research sample.

2

patients with tracheostomy

3

patients with chronic lung disease or respiratory symptoms undergoing bronchoscopy

Outcome Measures

Primary Outcome Measures

  1. pepsin concentration [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Meet criteria of study population
Exclusion Criteria:
  • Lack of informed consent/assent

  • Pulmonary disease in normal controls

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • Medical College of Wisconsin

Investigators

  • Principal Investigator: Nikki Johnston, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nikki Johnston, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00865995
Other Study ID Numbers:
  • CHW 08/26
  • GC 636
First Posted:
Mar 20, 2009
Last Update Posted:
Oct 23, 2013
Last Verified:
Oct 1, 2013
Keywords provided by Nikki Johnston, Assistant Professor, Medical College of Wisconsin
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2013