Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
In patients with hypertensive pulmonary edema there is no difference in the Borg rating of perceived exertion (BORG scale) one hour after hospital admission between furosemid and placebo.
Ethics approval
Approval from ethics commission of Stadt Wien on 28/03/2006.
Study design
Randomised, double-blind, placebo-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hypertensive pulmonary edema
Intervention
Intravenous furosemide versus intravenous placebo on top of standard medication.
Intervention type
Drug
Phase
Not Specified
Drug names
Furosemid
Primary outcome measures
Changes in dyspnoea severity one hour after hospital admission (BORG scale).
Secondary outcome measures
1. BORG scale at hours two, three and six
2. Visual analogue scale score at one, two, three and six hours
3. Blood pressure
4. Partial pressure of oxygen in arterial blood (paO2), partial pressure of carbon dioxide in arterial blood (paCO2), spot oxygen saturation (SpO2)
5. pH, BE, lactate
6. Safety: acute myocardial infarction, hypotension, intubation, catecholamines, cardiac arrest, death
Overall trial start date
01/05/2006
Overall trial end date
30/11/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Hypertensive pulmonary edema (Relative Risk [RR] more than 180 mmHg, crackles in auscultation)
2. Over 18 years of age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Women of childbearing potential
2. Chronic renal failure with renal replacement therapy
3. Acute ST-Elevation Myocardial Infarction (STEMI)
4. Need for intubation on arrival at scene
5. Need for catecholamines on arrival
6. Known incompatibilities to furosemide, urapidil or morphine hydrochloride
Recruitment start date
01/05/2006
Recruitment end date
30/11/2007
Locations
Countries of recruitment
Austria
Trial participating centre
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
Sponsor information
Organisation
Medical University of Vienna (Austria)
Sponsor details
Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Medical University of Vienna, Department of Emergency Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary