Pulmonary EdemaNCT00604227
Pulmonary Function at High-Altitude
A study testing Hypoxic Exposure in people with Pulmonary Edema, run by Heidelberg University at 1 site in Germany.
Trial summary
Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- Hypoxic Exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2005to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mountaineering ability required for reaching the Margherita hut (4559 m)
Who cannot join
- Borne above 1500 m
- Subjects with internal medical diseases like all cardiac diseases, all pulmonary diseases, Diabetes mellitus, infectious diseases, thyroid diseases, malignant diseases, hepatic or renal diseases,
- (Known) hypersensitivity to salbutamol or to another component of sultanol® or lidocaine, or to another component of xylocain® pump spray
- Intake of drugs, especially nifedipine, acetazolamide and glucocorticoids or of drugs interacting with sultanol® or xylocain® pump spray
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)
Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine the effects of broncho-constriction on the increase of closing volume by extensive lung function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m). As has been done in earlier studies, conventional thorax radiographs are used for verification of HAPE. In this study, the determination of the thoracic fluid quantity will be completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial function will be assessed to get further insight into the regulation of pulmonary vascular tone at altitude and in particular into the pathophysiology of HAPE.
- Conditions
- Pulmonary Edema
- Being tested
- Hypoxic Exposure
- Keywords
- high altitude pulmonary edema, pulmonary interstitial fluid, pulmonary function testing, hypoxia, pulmonary endothelial function, high altitude exposure without prior acclimatization
- Medical subject headings
- Pulmonary Edema, Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypoxic ExposureOther
ascent to 4559 m within 24 h without prior acclimatization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | high altitude exposure Receives: Other: Hypoxic Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of HAPE
Measured: during the 48 h stay at altitude
Secondary outcomes (3)
change of lung function parameters from low to high altitude
Measured: during the 48 h stay at altitude
markers of pulmonary endothelial function
Measured: during the 48 h stay at altitude
quantification of pulmonary interstitial fluid
Measured: during the 48 h stay at altitude
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJul 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Dehnert, MD, Principal investigator, University Hospital HeidelbergMarc M Berger, MD, Principal investigator, University Hospital HeidelbergPeter Bärtsch, MD, PhD, Study director, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604227
- Sponsor's protocol ID
- M2005
- Status last verified
- Nov 2007
- First submitted
- 17 Jan 2008
- Last updated
- 30 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Pulmonary Edema After Rapid Ascent to High Altitude (Margherita Hut, 4559 m)
- ClinicalTrials.gov ID
- NCT00604227
- Acronym / sponsor ID
- M2005
- Conditions
- Pulmonary Edema
- Keywords
- high altitude pulmonary edema, pulmonary interstitial fluid, pulmonary function testing, hypoxia, pulmonary endothelial function, high altitude exposure without prior acclimatization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Aug 2005 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine the effects of broncho-constriction on the increase of closing volume by extensive lung function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m). As has been done in earlier studies, conventional thorax radiographs are used for verification of HAPE. In this study, the determination of the thoracic fluid quantity will be completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial function will be assessed to get further insight into the regulation of pulmonary vascular tone at altitude and in particular into the pathophysiology of HAPE.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Hypoxic Exposurehigh altitude exposure |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mountaineering ability required for reaching the Margherita hut (4559 m)
Key exclusion criteria (5 listed)
- Borne above 1500 m
- Subjects with internal medical diseases like all cardiac diseases, all pulmonary diseases, Diabetes mellitus, infectious diseases, thyroid diseases, malignant diseases, hepatic or renal diseases,
- (Known) hypersensitivity to salbutamol or to another component of sultanol® or lidocaine, or to another component of xylocain® pump spray
- Intake of drugs, especially nifedipine, acetazolamide and glucocorticoids or of drugs interacting with sultanol® or xylocain® pump spray
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypoxic Exposureascent to 4559 m within 24 h without prior acclimatization | Other | 1 |
Primary outcome
development of HAPE
Time frame: during the 48 h stay at altitude
3 secondary outcomes
change of lung function parameters from low to high altitude
Time frame: during the 48 h stay at altitude
markers of pulmonary endothelial function
Time frame: during the 48 h stay at altitude
quantification of pulmonary interstitial fluid
Time frame: during the 48 h stay at altitude
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Dehnert, MD principal investigator
University Hospital Heidelberg
Marc M Berger, MD principal investigator
University Hospital Heidelberg
Peter Bärtsch, MD, PhD study director
University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypoxic Exposure in people with Pulmonary Edema, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of HAPE (time frame: during the 48 h stay at altitude). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2008.