Pepsin As A Biomarker For Aspiration

This study is currently recruiting participants.
Verified April 2012 by Medical College of Wisconsin
Sponsor:
Information provided by (Responsible Party):
Nikki Johnston, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00865995
First received: March 19, 2009
Last updated: April 12, 2012
Last verified: April 2012

March 19, 2009
April 12, 2012
February 2008
December 2012   (final data collection date for primary outcome measure)
pepsin concentration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00865995 on ClinicalTrials.gov Archive Site
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Pepsin As A Biomarker For Aspiration
Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux

Evaluation of tracheal pepsin as a biomarker for aspiration

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 bronchoaveolar 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

    1. children undergoing bronchoscopy; or with tracheostomies, or that are intubated
    2. critically ill, intubated children; and
    3. 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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Tracheal fluid

Non-Probability Sample

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

  • Aspiration
  • Gastroesophageal Reflux
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.
  • 1
    Normals
    Intervention: Procedure: Tracheal Lavage
  • 2
    patients undergoing bronchoscopy
  • 3
    patients with tracheostomy
  • 4
    Intubated patients in PICU
  • Intubated premature infants
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet criteria of study population

Exclusion Criteria:

  • Lack of informed consent/assent
  • Pulmonary disease in normal controls
Both
1 Year to 18 Years
Yes
Not Provided
United States
 
NCT00865995
CHW 08/26, GC 636
No
Nikki Johnston, Medical College of Wisconsin
Medical College of Wisconsin
Not Provided
Principal Investigator: Nikki Johnston, PhD Medical College of Wisconsin
Medical College of Wisconsin
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP