Protocol summary

Summary
Edema is referred to increase in interstitial fluid that is clinically evident. The main causes of generalized edema are heart failure, renal failure, nephrotic syndrome, glomerulonephritis and chronic liver failure. In some cases, edema is treated by management of the underlying disease. However, in some other cases edema may persist and become more severe that needs adjuvant treatments. Because use of diuretics such as furosemide and hydrochlorothiazide is not completely effective in treating severe refractory edema, use of some other diuretics is also recommended. In this double-blind clinical trial, weight and some lab data including blood urea nitrogen, serum creatinine, serum sodium, serum potassium, serum triglyceride and cholesterol of the 20 random adult patients with nephrotic syndrome who have refractory edema and normal BUN and creatinine and referred to nephrology clinic of Shiraz University of Medical Sciences will be measured; the patients should not have hypokalemia and other causes of edema such as heart failure or cirrhosis. Then the patients are divided into 2 groups with 10 members in each. The first group will be prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide and the second one will receive 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then, weight and mentioned lab data will be measured again. After that, all the patients will have 40 mg of furosemide daily for 2 weeks. Then, weight and mentioned lab data will be measured for one more time.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014081518798N1
Registration date: 2014-09-08, 1393/06/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Mohammad Amin Fallahzadeh
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1646 6976
Email address
fallahzadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz Nephrourology Research Center
Expected recruitment start date
2014-08-16, 1393/05/25
Expected recruitment end date
2015-01-16, 1393/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of using furosemide following acetazolamide and hydrochlorothiazide with furosemide and hydrochlorothiazide in treating refractory edema
Public title
Role of acetazolamide and hydrochlorothiazide followed by furosemide in treating edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1. Having refractory edema due to nephrotic syndrome 2. Normal BUN and creatinine 3. Being able to come for weekly visit 4. More than 18 years of age 5. Signing the informed consent form Exclusion Criteria: 1. Hypokalemia 2. Pregnancy 3. Renal transplant 4. Present malignancy 5. Severe acidosis 6. Using NSAIDs 7. Having another causes of edema including liver cirrhosis, heart failure
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Department of medical ethics and philosophy of health
Street address
Shiraz Medical School, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
93-01-18-7308

Health conditions studied

1

Description of health condition studied
Refractory edema in nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Incl.: congenital nephrotic syndrome, lipoid nephrosis

Primary outcomes

1

Description
Weight
Timepoint
3 weeks after the starting the drugs
Method of measurement
Using a scale

Secondary outcomes

1

Description
Blood Urea Nitrogen
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

2

Description
Serum Creatinine
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

3

Description
Serum Sodium
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

4

Description
Serum Potassium
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

5

Description
Serum Triglycerides
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

6

Description
Serum Cholesterol
Timepoint
3 weeks after starting the drugs
Method of measurement
By labratory

Intervention groups

1

Description
Intervention Arm: Using 250 mg,1 tablet, acetazolamide and 50 mg,1 tablet, hydrocholorothiazide daily for one week followed by 2 weeks use of 40mg ,1 tablet, furosemide daily.
Category
Treatment - Drugs

2

Description
Control Arm: Using 40 mg, 1 tablet, furosemide and 50 mg, 1 tablet, hydrocholorothiazide daily for one week followed by 2 weeks use of 40 mg,1 tablet, furosemide daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic of Shiraz University of Medical Sciences
Full name of responsible person
Mrs. Taghados
Street address
4th floor, Motahari Clinic, Namazi Square, Shiraz, Iran.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz Nephrourology Research Center
Full name of responsible person
Mahboobe Keshavarzi
Street address
Block 1, 3rd floor, Emam Reza Clinic, Namazee square, Shiraz, Iran.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz Nephrourology Research Center
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
Shiraz Medical School
Full name of responsible person
Mohammad Amin Fallahzadeh
Position
Medical Student
Other areas of specialty/work
Street address
Shiraz Medical School, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 1646 6976
Fax
Email
fallahzadm@sums.ac.ir, aminfa91@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz Medical School
Full name of responsible person
Mohammad Mehdi Sagheb
Position
Subspecialist of adult nephrology
Other areas of specialty/work
Street address
Shiraz Medical School, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 1229 8075
Fax
Email
saghebf@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz Medical School
Full name of responsible person
Mohammad Amin Fallahzadeh
Position
Medical Student
Other areas of specialty/work
Street address
Shiraz Medical School, Zand Avenue, Shiraz, Iran.
City
Shiraz
Postal code
Phone
+98 71 1646 6976
Fax
Email
fallahzadm@sums.ac.ir, aminfa91@gmail.com
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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