NCT01162161

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

July 13, 2010

Last Update Submit

September 22, 2015

Conditions

Pulmonary Edema

Keywords

sphingolipidceramidesphingomyelinase

Study Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • above the age of 18

You may not qualify if:

  • taking steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Clinic I, University Hospital Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Pulmonary Edema

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefan Krüger, MD, PhD

    RWTH Aachen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 14, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

May 1, 2013

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)