Prevention and Treatment of Immersion Pulmonary Edema

This study is currently recruiting participants.
Verified December 2013 by Duke University
Sponsor:
Collaborator:
Divers Alert Network
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00815646
First received: December 26, 2008
Last updated: December 27, 2013
Last verified: December 2013

December 26, 2008
December 27, 2013
January 2008
June 2014   (final data collection date for primary outcome measure)
Pulmonary artery pressure during cold water immersion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
PA pressure during cold water immersion [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00815646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention and Treatment of Immersion Pulmonary Edema
Effects of the Dive Reflex on Pulmonary Arterial and Pulmonary Artery Wedge Pressures in Subjects Who Have Experienced Immersion Pulmonary Edema

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.

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.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Immersion Pulmonary Edema (IPE)
  • Swimming Induced Pulmonary Edema (SIPE)
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
Experimental: Sildenafil
Measurements of pulmonary and systemic pressures during cold water immersion before and after sildenafil 50 mg orally.
Intervention: Drug: Sildenafil

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • History of immersion pulmonary edema

Exclusion Criteria:

  • Coronary artery disease, cardiomyopathy, heart valve disease
Both
18 Years to 55 Years
Yes
Contact: Richard Moon, MD 919-684-8762 ipedivestudy@duke.edu
United States
 
NCT00815646
Pro00003158
No
Duke University
Duke University
Divers Alert Network
Principal Investigator: Richard Moon, MD Duke University
Duke University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP