- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01910233
Registry of Patients With Acute Dyspnea in the Emergency Department
March 31, 2016 updated by: Prof. Dr. Michael Christ, Klinikum Nürnberg
Prospective Registry for Quality Assurance of Medical Care of Patients With Acute Dyspnea in the Emergency Department
This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg.
There is evidence that acute dyspnea is associated with a mortality rate of 10%, however acute dyspnea is not perceived as a life-threatening condition, both in public and in health care providers.
Our aim is to describe the patient collective concerning their demographics, baseline characteristics, type of referral and disposition, medical care processes and prognosis.
Secondly, we want to evaluate if the subjective risk assessment of emergency department personnel matches with objective risk stratification tools and the actual outcome of the studied patients.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a prospective registry of patients presenting with acute dyspnea to the emergency department of the city hospital in Nuremberg during May 23th 2013 and October 31th 2013.
To be included into the registry the patient has to express acute dyspnea.
Minor patients are not included.
The admission documents of the studied patients are accompanied by a questionnaire that has to be completed by the triage nurse and the attending physician.
The questionnaire includes items like professional experience and subjective assessment of patient's prognosis.
In addition the attending physician has to state if the evaluation of medical history was difficult, if previous medication is known and how likely the presence of heart failure as underlying condition is.
Data of the questionnaire, the patient record and the follow up contacts are entered in a SPSS database.
Finally, we measure the OPTIMIZE-HF score (Abraham et al. 2008) and the PRIDE mortality score (Baggish et al. 2007) in a retrospective manner in order to compare the subjective assessments with objective criteria.
Study Type
Observational
Enrollment (Actual)
947
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bavaria
-
Nuremberg, Bavaria, Germany, 90471
- Department of Emergency and Critical Care Medicine, City Hospital Nuremberg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients presenting to the emergency department of the city hospital Nuremberg
Description
Inclusion Criteria:
- expression of acute dyspnea in the emergency department
Exclusion Criteria:
- age < 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
adult patients with acute dyspnea in ED
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause mortality
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
demographics and baseline characteristics
Time Frame: 1 month
|
baseline characteristics as for example vital signs, medication, underlying disease condition (adjusted final diagnosis), medical history, concomitant diseases
|
1 month
|
medical care processes
Time Frame: 1 day
|
type of referral, disposition patterns, diagnostic and therapeutical measures
|
1 day
|
subjective and objective risk assessment
Time Frame: 1 month
|
data from the questionnaire completed by triage nurse and attending physician, OPTIMIZE-HF and PRIDE mortality score
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Christ, Prof., Klinikum Nürnberg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
July 25, 2013
First Submitted That Met QC Criteria
July 25, 2013
First Posted (Estimate)
July 29, 2013
Study Record Updates
Last Update Posted (Estimate)
April 1, 2016
Last Update Submitted That Met QC Criteria
March 31, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OOB01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Duke University; St. Paul's Hospital... and other collaboratorsActive, not recruitingHeart Diseases | Heart Failure | Transplant; Failure, Heart | Heart Transplant Failure and Rejection | Heart Failure,Congestive | Transplant FailureCanada, United States