Protocol summary

Summary
The study is aimed to evaluate the effect of 40 milligram of inhaled Furosemide versus placebo in patients with early diagnosis of cardiogenic pulmonary edema. The study is a randomized controlled clinical trial that will be conducted in Hazrat-e Rasool-e-Akhram and Firoozghar Hospitals affiliated by Iran University of Medical Sciences during the first half of 2018. This study will be double-blind in which patients and doctors assessing the clinical status of patients will not be aware of the intervention. All patients with primary diagnosis of acute pulmonary involvement will be included in the study, and the exclusion criteria are history of susceptibility to sulfa-containing drugs, inability of the patient to cooperate; unstable hemodynamics; requiring mechanical ventilation; decreased consciousness. 120 patients will be assigned to the treatment group (60) and control (60) using the blocked randomized method. In the treatment group, 40 milligram of Furosemide is inhaled in addition to routine treatment. In control group, Normal Saline will be prescribed as a placebo in addition to routine treatment. The intervention time is within the first 10 minutes of treatment. Patients in both groups will be evaluated at baseline and 10 minutes after intervention in terms of oxygen saturation, respiration rate, heart rate, arterial blood gases, dyspnea based on visual analog scale (VAS), Crackles and Wheezing and decreased lung sounds.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017101436753N1
Registration date: 2017-11-18, 1396/08/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-18, 1396/08/27
Registrant information
Name
Babak Mahshidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 9255
Email address
mahshidfar.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2017-09-28, 1396/07/06
Expected recruitment end date
2018-03-31, 1397/01/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of furosemide inhalation versus placebo in patients with acute cardiogenic pulmonary edema
Public title
Compare effect of furosemide inhalation versus placebo in patients with acute cardiogenic pulmonary edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the patients with acute cardiogenic edema will be included in the study. Exclusion criteria: not willing to participate in the study, history of susceptibility to sulfa drugs, unstable hemodynamics; requiring mechanical ventilation; decreased consciousness, accompany with another illness requiring treatment in the first 10 minutes of treatment with digoxin, beta blocker, beta-agonist and calcium; need to have another inhaling treatment in the first 10 minutes and need to have non-invasive ventilation.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.IUMS.REC.1365.9411307025

Health conditions studied

1

Description of health condition studied
Acute pulmonary oedema
ICD-10 code
I50.1
ICD-10 code description
Left ventricular failure

Primary outcomes

1

Description
Oxygen saturation
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Pulse oximeter

2

Description
Respiratory rate
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Number of breaths per minute

3

Description
Heart rate
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Heart beats at per minute

4

Description
Arterial blood gases
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Arterial blood gases test

5

Description
Dyspnea Severity
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
MMRC Dyspnea Severity Scale

Secondary outcomes

1

Description
Crackles
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Stethoscope

2

Description
Wheezing
Timepoint
Baseline and 10 minutes after intervention
Method of measurement
Stethoscope

Intervention groups

1

Description
Control group: Normal Saline as a placebo will be prescribed through nebulizer in addition to routine treatment at the first 10 minutes.
Category
Treatment - Drugs

2

Description
Intervention group: 40 milligram of Furosemide is inhaled through nebulizer in addition to routine treatment at the first 10 minutes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e Akram Hospital
Full name of responsible person
Amir Sadegh Alimardani
Street address
Niyayesh St, Sattar Khan St
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9255
Fax
Email
mahshidfar.b@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Babak Mahshidfar
Position
Emergency Medicine Specialist
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9255
Fax
Email
mahshidfar.b@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Amir Sadegh Alimardani
Position
Emergency Medicine Assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Phone
+98 21 6653 9255
Fax
Email
mahshidfar.b@iums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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