Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea

This study has been completed.
Sponsor:
Collaborator:
Roche Diagnostics AG, Switzerland
Information provided by (Responsible Party):
Joachim Saur, University Hospital Mannheim
ClinicalTrials.gov Identifier:
NCT01197586
First received: September 8, 2010
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

Establishing new biochemical markers in the differential diagnostics and risk stratification in heterogeneous patient collectives is becoming more and more important. The markers should be objective, reliable, reproducible, quick and cost effective as well as specific and sensitive. Concerning the differential diagnostics of "dyspnea", NT-pro-BNP plays the most important role for the evaluation of a cardiac origin. However, a corresponding biochemical marker for pulmonary stress is lacking. The aim of the study at hand therefore was the evaluation of surfactant protein B in the differential diagnostics of pulmonary and cardiac diseases.


Condition
Dyspnea
Cardiac Disease
Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Universitätsmedizin Mannheim:

Primary Outcome Measures:
  • Surfactant protein B serum levels [ Time Frame: Days 1, 3 and 7 ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients presenting with the symptom "dyspnea" in a university hospital emergency room

Criteria

Inclusion Criteria:

  • patients presenting with dyspnea and giving informed consent

Exclusion Criteria:

  • outpatients
  • lack or doubt of legal competence
  • indication for mechanical ventilation
  • pregnancy
  • palliative patients
  • CPAP/LTOT
  • BMI > 30 kg/m2
  • sepsis
  • anemia
  • dialysis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01197586

Locations
Germany
Universitaetsmedizin Mannheim
Mannheim, Germany, 68167
Sponsors and Collaborators
Universitätsmedizin Mannheim
Roche Diagnostics AG, Switzerland
Investigators
Principal Investigator: Joachim Saur, MD Universitätsmedizin Mannheim
  More Information

No publications provided

Responsible Party: Joachim Saur, Principal Investigator, University Hospital Mannheim
ClinicalTrials.gov Identifier: NCT01197586     History of Changes
Other Study ID Numbers: 2010_spb_ma
Study First Received: September 8, 2010
Last Updated: June 21, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Universitätsmedizin Mannheim:
surfactant protein B
differential diagnostics

Additional relevant MeSH terms:
Dyspnea
Heart Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cardiovascular Diseases
Pulmonary Surfactants
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014