Prevention and Treatment of Immersion Pulmonary Edema
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| First Received Date ICMJE | December 26, 2008 | ||||
| Last Updated Date | November 20, 2012 | ||||
| Start Date ICMJE | January 2008 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PA pressure during cold water immersion [ Time Frame: 1 day ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00815646 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention and Treatment of Immersion Pulmonary Edema | ||||
| Official Title ICMJE | Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Sildenafil
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.
Other Name: Viagra |
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| Study Arm (s) | Experimental: Sildenafil
Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
Intervention: Drug: Sildenafil |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00815646 | ||||
| Other Study ID Numbers ICMJE | Pro00003158 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Richard Moon, Duke University | ||||
| Study Sponsor ICMJE | Duke University | ||||
| Collaborators ICMJE | Divers Alert Network | ||||
| Investigators ICMJE |
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| Information Provided By | Duke University | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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