Prevention and Treatment of Immersion Pulmonary Edema

Early Phase 1

Completed

• Conditions: Immersion Pulmonary Edema (IPE); Swimming Induced Pulmonary Edema (SIPE)
• Interventions: Drug: Sildenafil

• Registration Number: NCT00815646
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-12-26
• Study First Submitted QC: 2008-12-29
• Study First Posted: 2008-12-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-25
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• History of immersion pulmonary edema

Exclusion Criteria

• Coronary artery disease, cardiomyopathy, heart valve disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sildenafil	Sildenafil	Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.

Primary Outcome Measures

Name	Time	Method
Pulmonary artery pressure during cold water immersion	1 day

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States