NCT00815646

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 30, 2008

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

7.9 years

First QC Date

December 26, 2008

Last Update Submit

January 25, 2016

Conditions

Immersion Pulmonary Edema (IPE)Swimming Induced Pulmonary Edema (SIPE)

Keywords

Immersion pulmonary edemaDivingSwimmingPulmonary edemaCold water immersion

Outcome Measures

Primary Outcomes (1)

  • Pulmonary artery pressure during cold water immersion

    1 day

Study Arms (1)

Sildenafil

EXPERIMENTAL

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

Drug: Sildenafil

Interventions

SildenafilDRUG

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.

Also known as: Viagra
Sildenafil

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of immersion pulmonary edema

You may not qualify if:

  • Coronary artery disease, cardiomyopathy, heart valve disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

  • Peacher DF, Pecorella SR, Freiberger JJ, Natoli MJ, Schinazi EA, Doar PO, Boso AE, Walker AJ, Gill M, Kernagis D, Uguccioni D, Moon RE. Effects of hyperoxia on ventilation and pulmonary hemodynamics during immersed prone exercise at 4.7 ATA: possible implications for immersion pulmonary edema. J Appl Physiol (1985). 2010 Jul;109(1):68-78. doi: 10.1152/japplphysiol.01431.2009. Epub 2010 Apr 29.

    PMID: 20431020BACKGROUND

  • Fraser JA, Peacher DF, Freiberger JJ, Natoli MJ, Schinazi EA, Beck IV, Walker JR, Doar PO, Boso AE, Walker AJ, Kernagis DN, Moon RE. Risk factors for immersion pulmonary edema: hyperoxia does not attenuate pulmonary hypertension associated with cold water-immersed prone exercise at 4.7 ATA. J Appl Physiol (1985). 2011 Mar;110(3):610-8. doi: 10.1152/japplphysiol.01088.2010. Epub 2010 Dec 9.

    PMID: 21148341BACKGROUND

  • Peacher DF, Martina SD, Otteni CE, Wester TE, Potter JF, Moon RE. Immersion pulmonary edema and comorbidities: case series and updated review. Med Sci Sports Exerc. 2015 Jun;47(6):1128-34. doi: 10.1249/MSS.0000000000000524.

    PMID: 25222821BACKGROUND

  • Moon RE, Martina SD, Peacher DF, Potter JF, Wester TE, Cherry AD, Natoli MJ, Otteni CE, Kernagis DN, White WD, Freiberger JJ. Swimming-Induced Pulmonary Edema: Pathophysiology and Risk Reduction With Sildenafil. Circulation. 2016 Mar 8;133(10):988-96. doi: 10.1161/CIRCULATIONAHA.115.019464. Epub 2016 Feb 16.

    PMID: 26882910DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Richard Moon, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2008

First Posted

December 30, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)