Prevention and Treatment of Immersion Pulmonary Edema
Primary Purpose
Immersion Pulmonary Edema (IPE), Swimming Induced Pulmonary Edema (SIPE)
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sildenafil
Sponsored by
About this trial
This is an interventional prevention trial for Immersion Pulmonary Edema (IPE) focused on measuring Immersion pulmonary edema, Diving, Swimming, Pulmonary edema, Cold water immersion
Eligibility Criteria
Inclusion Criteria:
- History of immersion pulmonary edema
Exclusion Criteria:
- Coronary artery disease, cardiomyopathy, heart valve disease
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sildenafil
Arm Description
Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
Outcomes
Primary Outcome Measures
Pulmonary artery pressure during cold water immersion
Secondary Outcome Measures
Full Information
NCT ID
NCT00815646
First Posted
December 26, 2008
Last Updated
January 25, 2016
Sponsor
Duke University
Collaborators
Divers Alert Network
1. Study Identification
Unique Protocol Identification Number
NCT00815646
Brief Title
Prevention and Treatment of Immersion Pulmonary Edema
Official Title
Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Divers Alert Network
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Immersion pulmonary edema (IPE) is a condition in which fluid fills the lungs during diving or swimming, particularly in cold water. Some individuals appear to be predisposed to developing IPE. DNA samples will be collected and stored, in order to compare the genetic profiles of individuals who have experienced IPE with those who have not. In a few individuals who have experienced IPE, we plan to measure the effects of cold water immersion on the blood pressure, cardiac output and the pressures in the pulmonary artery. These will be compared with similar measurements already obtained from normal individuals.
Detailed Description
Immersion pulmonary edema (IPE) is a condition that has sudden onset in swimmers and divers, and is characterized by cough, shortness of breath, decreased blood oxygen levels, and hemoptysis. The purpose of this study is to examine the effects of cold water immersion and the dive reflex on pulmonary arterial pressure and pulmonary capillary wedge pressure in those who have already experienced IPE, as well as explore the possibility of a genetic predisposition. Healthy nonsmoking subjects who have experienced IPE will be recruited for several cold-water immersion experiments and DNA analysis. Their pulmonary arterial and pulmonary arterial wedge pressures will be measured as they undergo immersed rest and exercise trials in thermoneutral and cold water. If the pressures increase with these trials as hypothesized, the effects of sildenafil administration (a pulmonary vasodilator) will be tested during a second trial. Blood will also be drawn for DNA analysis of certain genes with possible relation to IPE. Results of these tests will be compared with those of the general population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immersion Pulmonary Edema (IPE), Swimming Induced Pulmonary Edema (SIPE)
Keywords
Immersion pulmonary edema, Diving, Swimming, Pulmonary edema, Cold water immersion
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Viagra
Intervention Description
After measurement of the effect of cold water on cardiac output and pulmonary artery and wedge pressures, a single dose of sildenafil (50 mg) will be given orally, followed by similar hemodynamic measurements.
Primary Outcome Measure Information:
Title
Pulmonary artery pressure during cold water immersion
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
History of immersion pulmonary edema
Exclusion Criteria:
Coronary artery disease, cardiomyopathy, heart valve disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Moon, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20431020
Citation
Peacher DF, Pecorella SR, Freiberger JJ, Natoli MJ, Schinazi EA, Doar PO, Boso AE, Walker AJ, Gill M, Kernagis D, Uguccioni D, Moon RE. Effects of hyperoxia on ventilation and pulmonary hemodynamics during immersed prone exercise at 4.7 ATA: possible implications for immersion pulmonary edema. J Appl Physiol (1985). 2010 Jul;109(1):68-78. doi: 10.1152/japplphysiol.01431.2009. Epub 2010 Apr 29.
Results Reference
background
PubMed Identifier
21148341
Citation
Fraser JA, Peacher DF, Freiberger JJ, Natoli MJ, Schinazi EA, Beck IV, Walker JR, Doar PO, Boso AE, Walker AJ, Kernagis DN, Moon RE. Risk factors for immersion pulmonary edema: hyperoxia does not attenuate pulmonary hypertension associated with cold water-immersed prone exercise at 4.7 ATA. J Appl Physiol (1985). 2011 Mar;110(3):610-8. doi: 10.1152/japplphysiol.01088.2010. Epub 2010 Dec 9. Erratum In: J Appl Physiol. 2011 Dec;111(6):1888.
Results Reference
background
PubMed Identifier
25222821
Citation
Peacher DF, Martina SD, Otteni CE, Wester TE, Potter JF, Moon RE. Immersion pulmonary edema and comorbidities: case series and updated review. Med Sci Sports Exerc. 2015 Jun;47(6):1128-34. doi: 10.1249/MSS.0000000000000524.
Results Reference
background
PubMed Identifier
26882910
Citation
Moon RE, Martina SD, Peacher DF, Potter JF, Wester TE, Cherry AD, Natoli MJ, Otteni CE, Kernagis DN, White WD, Freiberger JJ. Swimming-Induced Pulmonary Edema: Pathophysiology and Risk Reduction With Sildenafil. Circulation. 2016 Mar 8;133(10):988-96. doi: 10.1161/CIRCULATIONAHA.115.019464. Epub 2016 Feb 16.
Results Reference
derived
Links:
URL
http://dukedivemedicine.org/?p=1656
Description
Duke Center for Hyperbaric Medicine and Environmental Physiology
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Prevention and Treatment of Immersion Pulmonary Edema
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