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Role of Sphingolipids in Pulmonary Edema (09-045)

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ClinicalTrials.gov Identifier: NCT01162161
Recruitment Status : Completed
First Posted : July 14, 2010
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
In this mono-center prospective study, the impact of changes in the sphingolipid metabolism in patients with pulmonary edema will be investigated.

Condition or disease
Pulmonary Edema

Detailed Description:

There will be three groups of patients:

  1. hydrostatic pulmonary edema
  2. toxic pulmonary edema
  3. 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

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Role of Sphingolipids in Pulmonary Edema
Study Start Date : July 2010
Primary Completion Date : December 2012
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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)


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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)

Criteria

Inclusion Criteria:

  • above the age of 18

Exclusion Criteria:

  • taking steroids
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162161


Locations
Germany
Medical Clinic I, University Hospital Aachen
Aachen, Nordrhein-Westfalen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Stefan Krüger, MD, PhD RWTH Aachen University
More Information

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01162161     History of Changes
Other Study ID Numbers: Sphingo-AC
First Posted: July 14, 2010    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by RWTH Aachen University:
sphingolipid
ceramide
sphingomyelinase

Additional relevant MeSH terms:
Edema
Pulmonary Edema
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases