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NCT03011151 · ClinicalTrials.gov registry record
Protease Activated Receptor-2 and Gastrointestinal Dysfunction in Critical Illness
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 99
- Enrollment target
NCT03011151: Completed study, sponsored by Boston Children's Hospital.
NCT03011151 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 99 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03011151 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 99 participants
- Enrollment target
Study Summary
Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier integrity, is associated with significant morbidity in critical illness. The mechanisms underlying GI dysfunction in critical illness are not well understood. GI dysfunction in surgery and critical illness has been associated with inflammation. There is evidence to suggest the protease-activated receptor 2 (PAR2) is a link between inflammation and GI dysfunction. PAR2 is a G-coupled receptor present throughout the GI tract. PAR2 mediates GI motility and epithelial barrier integrity. PAR2 is activated by PAR2 agonists, specifically GI serine proteases and zonulin, released under conditions of inflammation. In this study the investigators will examine the relationship between inflammation and PAR2 activation by PAR2 agonists and subsequent GI dysfunction in pediatric critically ill surgical patients. The overall hypothesis of this study is that PAR2 activation by PAR2 agonists, GI serine proteases and zonulin, released due to inflammation results in gastric dysmotility and loss of epithelial barrier integrity. In this study, the investigators will examine whether PAR2 agonist expression is increased and correlates with GI dysfunction in critically ill surgical pediatric patients. This proposal fills a knowledge gap in the understanding of mechanisms for GI dysfunction in critical illness, and will be applicable to all surgical and medical critically ill children.
Primary Outcome
PAR2 agonist activity will be measured by serum zonulin levels (ng/mL)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2024-06-30 |
What the finished NCT03011151 record still lists
NCT03011151 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 99 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03011151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03011151 about?
NCT03011151 is a clinical study titled "Protease Activated Receptor-2 and Gastrointestinal Dysfunction in Critical Illness". Gastrointestinal (GI) dysfunction affects up to 50% of medical and surgical critically ill children. GI dysfunction, specifically gastric dysmotility and loss of epithelial barrier integrity, is associated with significant morbidity in critical illness. The mechanisms underlying GI dysfunction in cr...
What is the current status of trial NCT03011151?
This trial is currently completed. The enrollment target is 99 participants. The study started on 2017-08-01. Estimated completion is 2024-06-30.
Who is sponsoring clinical trial NCT03011151?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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