Plastic Bronchitis and Protein Losing Enteropathy in Children With Single Ventricle Physiology
This study is ongoing, but not recruiting participants.
Sponsor:
Medical College of Wisconsin
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
William Clarke, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01563757
First received: March 23, 2012
Last updated: February 3, 2013
Last verified: February 2013
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Purpose
The investigators are studying what causes Plastic Bronchitis and Protein Losing Enteropathy. The investigators think that these problems are from too much of two small proteins called Vasoactive Intestinal Peptide (VIP) and Substance P. VIP and Substance P are important proteins in the body that normally tell the body to make small amounts of fluid and they help the intestines work. Normally, VIP and Substance P are made in the intestines and then destroyed in the lungs after they do their normal work. The investigators think that kids who have Plastic Bronchitis and/or Protein Losing Enteropathy who also had the Fontan surgery might have too much VIP and Substance P in their bodies. The investigators think this causes too much fluid to go in the lungs and too much protein in the intestines.
| Condition |
|---|
|
Fontan Physiology Patients With PB or PLE Fontan Physiology Patients Without PB or PLE |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | An Investigation Into The Potential Roles Of Vasoactive Intestinal Peptide And Substance P In The Pathophysiology Of Plastic Bronchitis And Protein Losing Enteropathy In Children With Palliated Single Ventricle Physiology |
Further study details as provided by Medical College of Wisconsin:
Primary Outcome Measures:
- Etiologic factors in the development of PLE and PB in patients with Fontan physiology [ Time Frame: During catheterization ] [ Designated as safety issue: No ]It is anticipated that results will demonstrate significant differences in venous, arterial and /or transpulmonary levels of VIP, Substance P or both among the various subject groups reflecting etiologic factors in the development of PLE and PB in patients with Fontan physiology.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Fontan Patients with PLE and PB
Fontan Patients with Protein Losing Enteropathy and Plastic Bronchitis
|
|
Fontan Patients w/out PLE & PB
Protein Losing Enteropathy and Plastic Bronchitis
|
| Glenn Physiology Patients |
|
2 ventricle heart with ASD
2 ventricle heart with Atrial Septal Defect
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 6 Months and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Children's Hospital of Wisconsin Catheterization Lab
Criteria
Inclusion Criteria:
- Fontan physiology patients with PB or PLE
- Fontan physiology patients without PB or PLE
- Glenn physiology patients
- 2 ventricle patients with Atrial Septal Defect
- Patient has scheduled cardiac catheterization (of right and left heart)
- Age is greater than 6 months
- Weight is greater than 10kg
Exclusion Criteria:
- Known Inflammatory Bowel Disease
- Hepatitis
- Congenital/ acquired liver disease
- Nephropathy
- Acute/ chronic renal dysfunction
- Active pulmonary hemorrhage
- Malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563757
Locations
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
| Principal Investigator: | Todd Gudausky, MD | Medical College of Wisconsin |
| Principal Investigator: | Jake Scott, MD | Medical College of Wisconsin |
| Principal Investigator: | William Clarke, MD, MS | Medical College of Wisconsin |
More Information
No publications provided
| Responsible Party: | William Clarke, Associate Professor, Anesthesiology/Clinical/Pediatrics, Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT01563757 History of Changes |
| Other Study ID Numbers: | CHW 12/28, GC 1479 |
| Study First Received: | March 23, 2012 |
| Last Updated: | February 3, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bronchitis Intestinal Diseases Protein-Losing Enteropathies Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Gastrointestinal Diseases Digestive System Diseases |
Vasoactive Intestinal Peptide Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013