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

Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427880
• Other study ID #: 7308
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2015
• Last updated: February 21, 2016
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Having refractory edema due to nephrotic syndrome

2. Having GFR>60 ml/min/1.73m2

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. active malignancy or infection

5. acidosis

6. Using NSAIDs

7. Having another causes of edema including liver cirrhosis, heart failure

8. Neurologic or psychiatric problem hindering adherence to the study protocol

Study Design

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

Related Conditions & MeSH terms

• Edema
• Nephrosis
• Nephrotic Syndrome

Intervention

Drug:
• Acetazolamide and Hydrochlorothiazide Followed by Furosemide

• Furosemide and Hydrochlorothiazide Followed by Furosemide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in weight at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in systolic and diastolic blood pressure at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in serum sodium at the end of third week		Baseline and at the end of the third week	Yes
Secondary	Change from baseline in serum potassium at the end of third week		Baseline and at the end of the third week	Yes
Secondary	Change from baseline in blood urea nitrogen at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in serum creatinine at the end of third week		At the start and at the end of the third week	No
Secondary	Change from baseline in serum albumin at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in urine sodium at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in urine potassium at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in 24-hour urine volume at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in 24-hour urine creatinine at the end of third week		Baseline and at the end of the third week	No
Secondary	Change from baseline in 24-hour urine protein at the end of third week		Baseline and at the end of the third week	No