Condition category
Respiratory
Date applied
28/03/2006
Date assigned
03/08/2006
Last edited
03/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wolfgang Schreiber

ORCID ID

Contact details

Waehringer Guertel 18-20/6D
Vienna
1090
Austria

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

http://www.meduniwien.ac.at/

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

Publication citations

Additional files

Editorial Notes