Role of Acetazolamide and Hydrochlorothiazide Followed by Furosemide in Treating Edema

Condition(s) targeted: Nephrotic Syndrome; Edema

Intervention: Acetazolamide and Hydrochlorothiazide Followed by Furosemide (Drug); Furosemide and Hydrochlorothiazide Followed by Furosemide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Shiraz University of Medical Sciences

Official(s) and/or principal investigator(s):
Mohammad Mahdi Sagheb, MD, Study Chair, Affiliation: Nephrologist at Shiraz University of Medical Science

The purpose of this study is to determine whether using furosemide following acetazolamide is effective in treating refractory edema associated with nephrotic syndrome.

Official title: Comparing the Effect of Using Furosemide Following Acetazolamide and Hydrochlorothiazide With Furosemide and Hydrochlorothiazide in Treating Refractory Edema

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in weight at the end of third week

Secondary outcome:

Change from Baseline in 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 triglycerides at the end of third week

Change from Baseline in serum cholesterol 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

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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. Having the minimum age of 18 years 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

Related publications:

Soleimani M. A novel target for diuretic therapy. Iran J Kidney Dis. 2012 Nov;6(6):419-25.

Starting date: July 2014
Last updated: April 22, 2015