Prevention and Treatment of Immersion Pulmonary Edema
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immersion Pulmonary Edema (IPE) Swimming Induced Pulmonary Edema (SIPE) |
Drug: Sildenafil |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema |
- PA pressure during cold water immersion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sildenafil
Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- History of immersion pulmonary edema
Exclusion Criteria:
- Coronary artery disease, cardiomyopathy, heart valve disease
Contacts and Locations| Contact: Richard Moon, MD | 919-684-8762 | ipedivestudy@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Richard E Moon, MD 919-684-8762 richard.moon@duke.edu | |
| Principal Investigator: | Richard Moon, MD | Duke University |
More Information
Additional Information:
Publications:
| Responsible Party: | Richard Moon, Professor of Anesthesiology, Duke University |
| ClinicalTrials.gov Identifier: | NCT00815646 History of Changes |
| Other Study ID Numbers: | Pro00003158 |
| Study First Received: | December 26, 2008 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Immersion pulmonary edema Diving Swimming Pulmonary edema Cold water immersion |
Additional relevant MeSH terms:
|
Edema Pulmonary Edema Signs and Symptoms Lung Diseases Respiratory Tract Diseases Sildenafil Vasodilator Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013