Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Nephrotic Edema

Sponsor

Shiraz University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT02427880

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome Edema	Drug: Acetazolamide and Hydrochlorothiazide Followed by Furosemide Drug: Furosemide and Hydrochlorothiazide Followed by Furosemide	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acetazolamide 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.	Drug: Acetazolamide and Hydrochlorothiazide Followed by Furosemide Other Names: Diamox Sequels and Microzide Followed by Lasix
Active Comparator: Furosemide 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.	Drug: Furosemide and Hydrochlorothiazide Followed by Furosemide Other Names: Lasix and Microzide Followed by Lasix

Arm

Intervention/Treatment

Experimental: Acetazolamide

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.

Drug: Acetazolamide and Hydrochlorothiazide Followed by Furosemide

Other Names:

Diamox Sequels and Microzide Followed by Lasix

Active Comparator: Furosemide

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.

Drug: Furosemide and Hydrochlorothiazide Followed by Furosemide

Other Names:

Lasix and Microzide Followed by Lasix

Outcome Measures

Primary Outcome Measures

Change from baseline in weight at the end of third week [Baseline and at the end of the third week]

Secondary Outcome Measures

Change from baseline in systolic and diastolic blood pressure at the end of third week [Baseline and at the end of the third week]
Change from baseline in serum sodium at the end of third week [Baseline and at the end of the third week]
Change from baseline in serum potassium at the end of third week [Baseline and at the end of the third week]
Change from baseline in blood urea nitrogen at the end of third week [Baseline and at the end of the third week]
Change from baseline in serum creatinine at the end of third week [At the start and at the end of the third week]
Change from baseline in serum albumin at the end of third week [Baseline and at the end of the third week]
Change from baseline in urine sodium at the end of third week [Baseline and at the end of the third week]
Change from baseline in urine potassium at the end of third week [Baseline and at the end of the third week]
Change from baseline in 24-hour urine volume at the end of third week [Baseline and at the end of the third week]
Change from baseline in 24-hour urine creatinine at the end of third week [Baseline and at the end of the third week]
Change from baseline in 24-hour urine protein at the end of third week [Baseline and at the end of the third week]