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

ISRCTN ISRCTN93135084
DOI https://doi.org/10.1186/ISRCTN93135084
Secondary identifying numbers N/A
Submission date
28/03/2006
Registration date
03/08/2006
Last edited
08/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wolfgang Schreiber
Scientific

Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Study information

Study designRandomised, double-blind, placebo-controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleEffect of furosemide versus placebo on quality of life in hypertensive patients with pulmonary edema
Study objectivesIn 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) studiedHypertensive pulmonary edema
InterventionIntravenous furosemide versus intravenous placebo on top of standard medication.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Furosemide
Primary outcome measureChanges in dyspnoea severity one hour after hospital admission (BORG scale).
Secondary outcome measures1. 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 study start date01/05/2006
Completion date30/11/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Total final enrolment59
Key inclusion criteria1. Hypertensive pulmonary edema (Relative Risk [RR] more than 180 mmHg, crackles in auscultation)
2. Over 18 years of age
Key exclusion criteria1. 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 enrolment01/05/2006
Date of final enrolment30/11/2007

Locations

Countries of recruitment

  • Austria

Study participating centre

Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Sponsor information

Medical University of Vienna (Austria)
University/education

Department of Emergency Medicine
Waehringer Guertel 18-20/6D
Vienna
1090
Austria

Website http://www.meduniwien.ac.at/
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

University/education

Medical University of Vienna, Department of Emergency Medicine

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

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