Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Nephrotic Edema
Primary Purpose
Nephrotic Syndrome, Edema
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Acetazolamide and Hydrochlorothiazide Followed by Furosemide
Furosemide and Hydrochlorothiazide Followed by Furosemide
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Edema, Nephrotic syndrome, Acetazolamide, Furosemide
Eligibility Criteria
Inclusion Criteria:
- Having refractory edema due to nephrotic syndrome
- Having GFR>60 ml/min/1.73m2
- Being able to come for weekly visit
- Having the minimum age of 18 years
- Signing the informed consent form
Exclusion Criteria:
- Hypokalemia
- Pregnancy
- Renal transplant
- active malignancy or infection
- acidosis
- Using NSAIDs
- Having another causes of edema including liver cirrhosis, heart failure
- Neurologic or psychiatric problem hindering adherence to the study protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acetazolamide
Furosemide
Arm Description
Each patient receives 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then they are prescribed 40 mg of furosemide daily for 2 weeks.
Each patient is prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide daily for 1 week. Then they receive 40 mg of furosemide daily for 2 weeks.
Outcomes
Primary Outcome Measures
Change from baseline in weight at the end of third week
Secondary Outcome Measures
Change from baseline in systolic and diastolic blood pressure at the end of third week
Change from baseline in serum sodium at the end of third week
Change from baseline in serum potassium at the end of third week
Change from baseline in blood urea nitrogen at the end of third week
Change from baseline in serum creatinine at the end of third week
Change from baseline in serum albumin at the end of third week
Change from baseline in urine sodium at the end of third week
Change from baseline in urine potassium at the end of third week
Change from baseline in 24-hour urine volume at the end of third week
Change from baseline in 24-hour urine creatinine at the end of third week
Change from baseline in 24-hour urine protein at the end of third week
Full Information
NCT ID
NCT02427880
First Posted
April 20, 2015
Last Updated
February 21, 2016
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02427880
Brief Title
Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Nephrotic Edema
Official Title
Acetazolamide and Hydrochlorothiazide Followed by Furosemide Versus Hydrochlorothiazide and Furosemide Followed by Furosemide for the Treatment of Adults With Refractory Nephrotic Edema: A Randomized, Double-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome.
Detailed Description
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 albumin, urine sodium, urine potassium, 24-hour urine volume, 24-hour urine protein and 24-hour urine creatinine of 20 random adult patients with nephrotic syndrome who have refractory edema and GFR>60 ml/min/1.73m2 and are 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome, Edema
Keywords
Edema, Nephrotic syndrome, Acetazolamide, Furosemide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acetazolamide
Arm Type
Experimental
Arm Description
Each patient receives 250 mg of acetazolamide and 50 mg of hydrochlorothiazide daily for 1 week. Then they are prescribed 40 mg of furosemide daily for 2 weeks.
Arm Title
Furosemide
Arm Type
Active Comparator
Arm Description
Each patient is prescribed 40 mg of furosemide and 50 mg of hydrochlorothiazide daily for 1 week. Then they receive 40 mg of furosemide daily for 2 weeks.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide and Hydrochlorothiazide Followed by Furosemide
Other Intervention Name(s)
Diamox Sequels and Microzide Followed by Lasix
Intervention Type
Drug
Intervention Name(s)
Furosemide and Hydrochlorothiazide Followed by Furosemide
Other Intervention Name(s)
Lasix and Microzide Followed by Lasix
Primary Outcome Measure Information:
Title
Change from baseline in weight at the end of third week
Time Frame
Baseline and at the end of the third week
Secondary Outcome Measure Information:
Title
Change from baseline in systolic and diastolic blood pressure at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in serum sodium at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in serum potassium at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in blood urea nitrogen at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in serum creatinine at the end of third week
Time Frame
At the start and at the end of the third week
Title
Change from baseline in serum albumin at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in urine sodium at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in urine potassium at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in 24-hour urine volume at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in 24-hour urine creatinine at the end of third week
Time Frame
Baseline and at the end of the third week
Title
Change from baseline in 24-hour urine protein at the end of third week
Time Frame
Baseline and at the end of the third week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having refractory edema due to nephrotic syndrome
Having GFR>60 ml/min/1.73m2
Being able to come for weekly visit
Having the minimum age of 18 years
Signing the informed consent form
Exclusion Criteria:
Hypokalemia
Pregnancy
Renal transplant
active malignancy or infection
acidosis
Using NSAIDs
Having another causes of edema including liver cirrhosis, heart failure
Neurologic or psychiatric problem hindering adherence to the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Mahdi Sagheb, MD
Organizational Affiliation
Nephrologist at Shiraz University of Medical Science
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
23146978
Citation
Soleimani M. A novel target for diuretic therapy. Iran J Kidney Dis. 2012 Nov;6(6):419-25.
Results Reference
background
Learn more about this trial
Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Nephrotic Edema
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