Pepsin As A Biomarker For Aspiration
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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 |
- pepsin concentration [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Tracheal fluid
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Normals
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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.
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2
patients undergoing bronchoscopy
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3
patients with tracheostomy
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4
Intubated patients in PICU
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| Intubated premature infants |
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 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:
- to determine the frequency of pepsin contamination of children without chronic respiratory disease undergoing elective surgery with intubation
to determine frequency of tracheal pepsin and lipid laden macrophages (LLM) in
- children undergoing bronchoscopy; or with tracheostomies, or that are intubated
- critically ill, intubated children; and
- children with tracheostomies
- to compare the presence or absence and concentration of pepsin to the presence of LLM
- 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 |
Normal children undergoing general endotracheal anesthesia Children with tracheostomies Children undergoing bronchoscopy Intubated children in PICU
Inclusion Criteria:
- Meet criteria of study population
Exclusion Criteria:
- Lack of informed consent/assent
- Pulmonary disease in normal controls
Contacts and Locations| United States, Wisconsin | |
| Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Steven Werlin, MD 414-266-3690 swerlin@mcw.edu | |
| 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: | April 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Medical College of Wisconsin:
|
pepsin aspiration GE reflux |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases |
Digestive System Diseases Pepsin A Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013