Role of Sphingolipids in Pulmonary Edema (09-045)

This study is currently recruiting participants.
Verified December 2012 by RWTH Aachen University
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01162161
First received: July 13, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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


Condition
Pulmonary Edema

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Role of Sphingolipids in Pulmonary Edema

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Estimated Enrollment: 70
Study Start Date: July 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162161

Contacts
Contact: Stefan Krueger, PD Dr. med. 0049-241-8085152 stkrueger@ukaachen.de

Locations
Germany
Medical Clinic I, University Hospital Aachen Recruiting
Aachen, Nordrhein-Westfalen, Germany, 52074
Contact: Stefan Krüger, PD Dr. med.       stkrueger@ukaachen.de   
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Stefan Krüger, MD, PhD RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01162161     History of Changes
Other Study ID Numbers: Sphingo-AC
Study First Received: July 13, 2010
Last Updated: December 13, 2012
Health Authority: Germany: Ethics Committee

Keywords provided by RWTH Aachen University:
sphingolipid
ceramide
sphingomyelinase

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

ClinicalTrials.gov processed this record on April 14, 2014