Pulmonary Edema09-045NCT01162161
Role of Sphingolipids in Pulmonary Edema
An observational study of Pulmonary Edema, run by RWTH Aachen University at 1 site in Germany.
Trial summary
In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to May 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3 groups first group: patients with a lung oedema because of a pneumonia (about 30 patients) second group: patients with a lung oedema because of cardiac insufficiency (about 25 patients) third group: patients without any lung oedema (about 15 patients)
Who may be able to join
- above the age of 18
Who cannot join
- taking steroids
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical Clinic I, University Hospital Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.
Read the detailed description
There will be three groups of patients:
- hydrostatic pulmonary edema
- toxic pulmonary edema
- not ventilated patients without any pulmonary edema
Samples of a routine bronchoalveolar lavage and EDTA-blood will be analysed in respect of sphingolipids, ceramide, sphingomyelin-phosphodiesterase and several cytokines.
- Conditions
- Pulmonary Edema
- Keywords
- sphingolipid, ceramide, sphingomyelinase
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hydrostatic pulmonary edema | patients with a pulmonary edema caused by chronic heart failure | |
| toxic pulmonary edema | patients with a pulmonary edema preceded by pneumonia | |
| control group | not ventilated patients without any pulmonary edema receiving a bronchoscopy due to another pulmonary problem (no pneumonia, no heart failure) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionMay 2013
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Krüger, MD, PhD, Principal investigator, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162161
- Sponsor's protocol ID
- Sphingo-AC
- Acronym
- 09-045
- Status last verified
- Sep 2015
- First submitted
- 13 Jul 2010
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sphingolipids in Pulmonary Edema
- ClinicalTrials.gov ID
- NCT01162161
- Acronym / sponsor ID
- 09-045 / Sphingo-AC
- Conditions
- Pulmonary Edema
- Keywords
- sphingolipid, ceramide, sphingomyelinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 14 Jul 2010 (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.
In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.
Detailed description
There will be three groups of patients:
- hydrostatic pulmonary edema
- toxic pulmonary edema
- not ventilated patients without any pulmonary edema
Samples of a routine bronchoalveolar lavage and EDTA-blood will be analysed in respect of sphingolipids, ceramide, sphingomyelin-phosphodiesterase and several cytokines.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hydrostatic pulmonary edema | – | –patients with a pulmonary edema caused by chronic heart failure |
| toxic pulmonary edema | – | –patients with a pulmonary edema preceded by pneumonia |
| control group | – | –not ventilated patients without any pulmonary edema receiving a bronchoscopy due to another pulmonary problem (no pneumonia, no heart failure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 groups first group: patients with a lung oedema because of a pneumonia (about 30 patients) second group: patients with a lung oedema because of cardiac insufficiency (about 25 patients) third group: patients without any lung oedema (about 15 patients)
Key inclusion criteria (1 listed)
- above the age of 18
Key exclusion criteria (1 listed)
- taking steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 23 Sep 2015.
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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.
Stefan Krüger, MD, PhD principal investigator
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Edema, run by RWTH Aachen 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 1 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 23 Sep 2015. 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.
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 23 Sep 2015.