Pepsin As A Biomarker For Aspiration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00865995|
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : October 23, 2013
|Condition or disease||Intervention/treatment|
|Aspiration Gastroesophageal Reflux||Procedure: Tracheal Lavage|
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:
- 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 with chronic respiratory disease or symptoms and in 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.
|Study Type :||Observational|
|Actual Enrollment :||76 participants|
|Observational Model:||Case Control|
|Official Title:||Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux|
|Study Start Date :||February 2008|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
patients with tracheostomy
patients with chronic lung disease or respiratory symptoms undergoing bronchoscopy
- pepsin concentration [ Time Frame: 1 day ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00865995
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Nikki Johnston, PhD||Medical College of Wisconsin|