NCT01794130

Brief Summary

The aim of this investigation is to determine the incidence of silent interstitial pulmonary edema by chest ultrasound at moderate altitude (3905m). Secondary endpoints are to detect a suspected association with acute mountain sickness (AMS), co-morbidities and endothelial dysfunction (marker of hypoxia responses, endothelial damage and inflammation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2013

Completed
Last Updated

February 18, 2013

Status Verified

February 1, 2013

Enrollment Period

Same day

First QC Date

February 14, 2013

Last Update Submit

February 15, 2013

Conditions

Acute Mountain SicknessSubclinical High Altitude Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • Changes in the number of beta-lines in chest sonography

    as marker of subclinical pulmonary edema

    at 0 (arrival at 3830m), 9, 24, 48 and 72 hours, and at day 7

Secondary Outcomes (2)

  • Changes from baseline of optic nerve sheath diameter

    at 0 (arrival at 3830m), 3, 9, 24, 48 and 72 hours, and at day 7

  • Changes from baseline in RNA expression in circulating polymorphonucleated

    at 9, 24, 72 hours and day 7

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • healthy of age \>18y

You may not qualify if:

  • cardiac failure
  • chronic kidney disease
  • chronic pulmonary disease
  • acute lung/heart/kidney/brain conditions
  • neoplastic disease
  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Mountain Emergency Medicine, Eurac research

Bolzano, Provincia autonoma di Bolzano, 39100, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Altitude Sickness

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Giacomo Strapazzon, MD

    Institute of Mountain Emergency Medicine, Eurac research

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 18, 2013

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 18, 2013

Record last verified: 2013-02

Locations

IT(1)