Effect of furosemide versus placebo on quality of life in hypertensive patients with pulmonary edema

ISRCTN	ISRCTN93135084
DOI	https://doi.org/10.1186/ISRCTN93135084
Protocol serial number	N/A
Sponsor	Medical University of Vienna (Austria)
Funder	Medical University of Vienna, Department of Emergency Medicine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Wolfgang Schreiber
Scientific

Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Primary study design	Interventional
Study design	Randomised, double-blind, placebo-controlled study
Secondary study design	Randomised controlled trial
Scientific title	Effect of furosemide versus placebo on quality of life in hypertensive patients with pulmonary edema
Study objectives	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(s)	Approval from ethics commission of Stadt Wien on 28/03/2006.
Health condition(s) or problem(s) studied	Hypertensive pulmonary edema
Intervention	Intravenous furosemide versus intravenous placebo on top of standard medication.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Furosemide
Primary outcome measure(s)	Changes in dyspnoea severity one hour after hospital admission (BORG scale).
Key secondary outcome measure(s)	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
Completion date	30/11/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	59
Key inclusion criteria	1. Hypertensive pulmonary edema (Relative Risk [RR] more than 180 mmHg, crackles in auscultation) 2. Over 18 years of age
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	30/11/2007

Waehringer Guertel 18-20/6D

Vienna
1090
Austria

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2011	08/01/2021	Yes	No

08/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.