Pulmonary edema is one of the most common acute respiratory disorders that diagnosis and treatment of the disease still remain as a health problem. So, the aim of this study is to compare the efficacy of intravenous Furosemide and nebulized Furosemide in control of the symptoms of the patients with pulmonary edem.
in this clinical trial, 85 patients with pulmonary edema wil enroll . Patients will randomly divide into two groups. In the intervention group the patients will receive nebulized Furosemide at a dose of 1 mg for 20 minutes diluted in 2 ml of sodium chloride 0.9% and in the control group the patients will receive intravenous Furosemide at a dose of 1mg / kg. Then, hemodynamic parameters and estimation of the clinical severity of the pulmonary edema in both groups will assess for two hours.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030332853N1
Registration date:2017-03-29, 1396/01/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-29, 1396/01/09
Registrant information
Name
Somaye Shaabani
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8317
Email address
shaabani.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between Intravenous Furosemide and Nebulized Furosemide in Controlling the Symptoms of the Patients with Pulmonary Edema
Public title
Comparison between two different routes of Furosemide administration in Patients with Pulmonary Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with shortness of breath during the past six hours, patients with clinical signs of pulmonary edema (tachypnea, increased lung function, use of accessory muscles, crackles, wheezes and gallop rhythm), and radiographically diagnosis of pulmonary edema.
Exclusion criteria:
Cardiogenic shock and blood pressure less than 90 mmHg, noncardiogenic pulmonary edema, myocardial infarction, severe heart valve disease, history of pulmonary obstructive disease, patients requiring intubation, cardiac arrhythmias, liver failure, cancer, sensitivity to Furosemide , patient’s dissatisfaction and pregnancy.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
85
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blv
City
Ahvaz
Postal code
Approval date
2016-01-01, 1394/10/11
Ethics committee reference number
IR.AJUMS.REC.1394.448
Health conditions studied
1
Description of health condition studied
Pulmonary edema
ICD-10 code
J81.0
ICD-10 code description
Acute pulmonary edema
Primary outcomes
1
Description
Dyspnea severity
Timepoint
15,30,60 and 120 minutes after treatment
Method of measurement
Dyspnea Scale criteria
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group the patients will receive nebulized furosemide at a dose of 1 mg furosemide for 20 minutes in 2 ml of sodium chloride 0.9%
Category
Treatment - Drugs
2
Description
The control group the patients will receive intravenous furosemide at a dose of 1mg / kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Somaye Shaabani
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Somaye Shaabani
Street address
Farvardin Blv
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Somaye Shaabani
Position
M.D
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
+98 61 3374 3009
Fax
Email
s.shaabani@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Somaye Shaabani
Position
M.D
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
+98 61 3374 3009
Fax
Email
s.shaabani@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Somaye Shaabani
Position
Resident
Other areas of specialty/work
Street address
Farvardin Blv
City
Ahvaz
Postal code
Phone
00
Fax
Email
somayehshaabani@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)