Prevention and Treatment of Immersion Pulmonary Edema

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Pulmonary artery 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: December 2014
Estimated Primary Completion Date: June 2014 (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
Criteria

Inclusion Criteria:

  • History of immersion pulmonary edema

Exclusion Criteria:

  • Coronary artery disease, cardiomyopathy, heart valve disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815646

Contacts
Contact: Richard Moon, MD 919-684-8762 ipedivestudy@duke.edu

Locations
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   
Sponsors and Collaborators
Duke University
Divers Alert Network
Investigators
Principal Investigator: Richard Moon, MD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00815646     History of Changes
Other Study ID Numbers: Pro00003158
Study First Received: December 26, 2008
Last Updated: December 27, 2013
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
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014