DyspneaNCT01197586
Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea
An observational study of Dyspnea and Cardiac Disease, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyspnea, Cardiac Disease, Pulmonary Disease
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting with the symptom "dyspnea" in a university hospital emergency room
Who may be able to join
- patients presenting with dyspnea and giving informed consent
Who cannot join
- outpatients
- lack or doubt of legal competence
- indication for mechanical ventilation
- pregnancy
- palliative patients
- CPAP/LTOT
Show all 10Show fewer
- BMI > 30 kg/m2
- sepsis
- anemia
- dialysis
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Dyspnea, Cardiac Disease, Pulmonary Disease
- Keywords
- surfactant protein B, differential diagnostics
- Medical subject headings
- Dyspnea, Heart Diseases, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Surfactant protein B serum levels
Measured: Days 1, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Joachim Saur, Universitätsmedizin Mannheim
- Investigators
- Joachim Saur, MD, Principal investigator, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197586
- Sponsor's protocol ID
- 2010_spb_ma
- Status last verified
- Jun 2013
- First submitted
- 8 Sep 2010
- Last updated
- 24 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surfactant Protein B in the Differential Diagnostics of Dyspnea
- ClinicalTrials.gov ID
- NCT01197586
- Acronym / sponsor ID
- 2010_spb_ma
- Conditions
- Dyspnea, Cardiac Disease, Pulmonary Disease
- Keywords
- surfactant protein B, differential diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting with the symptom "dyspnea" in a university hospital emergency room
Key inclusion criteria (1 listed)
- patients presenting with dyspnea and giving informed consent
Key exclusion criteria (10 listed)
- outpatients
- lack or doubt of legal competence
- indication for mechanical ventilation
- pregnancy
- palliative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surfactant protein B serum levels
Time frame: Days 1, 3 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Saur, MD principal investigator
Universitätsmedizin Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Cardiac Disease, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surfactant protein B serum levels (time frame: Days 1, 3 and 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.