Role of Sphingolipids in Pulmonary Edema (09-045)

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014