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Plastic Bronchitis and Protein Losing Enteropathy in Children With Single Ventricle Physiology

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563757
First Posted: March 27, 2012
Last Update Posted: October 29, 2013
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.
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
William Clarke, Medical College of Wisconsin
  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

Resource links provided by NLM:


Further study details as provided by William Clarke, 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 ]
    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.


Enrollment: 20
Study Start Date: March 2012
Study Completion Date: September 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

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
First Submitted: March 23, 2012
First Posted: March 27, 2012
Last Update Posted: October 29, 2013
Last Verified: October 2013

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
Gastrointestinal Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs