Pepsin As A Biomarker For Aspiration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nikki Johnston, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00865995
First received: March 19, 2009
Last updated: October 22, 2013
Last verified: October 2013
  Purpose

Evaluation of tracheal pepsin as a biomarker for aspiration


Condition Intervention
Aspiration
Gastroesophageal Reflux
Procedure: Tracheal Lavage

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • pepsin concentration [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Tracheal fluid


Enrollment: 76
Study Start Date: February 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal children undergoing general endotracheal anesthesia Children with tracheostomies Children undergoing bronchoscopy Intubated children in PICU

Criteria

Inclusion Criteria:

  • Meet criteria of study population

Exclusion Criteria:

  • Lack of informed consent/assent
  • Pulmonary disease in normal controls
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00865995

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: Nikki Johnston, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00865995     History of Changes
Other Study ID Numbers: CHW 08/26, GC 636
Study First Received: March 19, 2009
Last Updated: October 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
pepsin
aspiration
GE reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014