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

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux; Aspiration
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Meet criteria of study population

Exclusion Criteria:

• Lack of informed consent/assent
• Pulmonary disease in normal controls

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pepsin concentration	1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 19, 2009
• First Submitted That Met QC Criteria: March 19, 2009
• First Posted (Estimate): March 20, 2009

Study Record Updates

• Last Update Posted (Estimate): October 23, 2013
• Last Update Submitted That Met QC Criteria: October 22, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: pepsin; aspiration; GE reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: CHW 08/26; GC 636