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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN93135084 |
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Date of registration:
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03/08/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of furosemid versus placebo on quality of life in hypertensive patients with pulmonary edema
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Scientific title:
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Date of first enrolment:
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01/05/2006 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN93135084 |
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Study type:
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Interventional |
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Study design:
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Randomised, double-blind, placebo-controlled study (Treatment)
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Wolfgang
Schreiber |
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Address:
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Waehringer Guertel 18-20/6D
1090
Vienna
Austria |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Hypertensive pulmonary edema (Relative Risk [RR] more than 180 mmHg, crackles in auscultation)
2. Over 18 years of age
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertensive pulmonary edema
Respiratory
Hypertensive pulmonary edema
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Intervention(s)
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Intravenous furosemide versus intravenous placebo on top of standard medication.
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Primary Outcome(s)
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Changes in dyspnoea severity one hour after hospital admission (BORG scale).
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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Medical University of Vienna, Department of Emergency Medicine
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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