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 |
- 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
Scientific
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
Study information
| 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 |
Eligibility
| 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 |
Locations
Countries of recruitment
- Austria
Study participating centre
Waehringer Guertel 18-20/6D
Vienna
1090
Austria
1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
