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

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ClinicalTrials.gov Identifier: NCT02427880
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Mohammad Amin Fallahzadeh, Shiraz University of Medical Sciences

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 Type : Interventional  (Clinical Trial)
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 : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: 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 Name: Lasix and Microzide Followed by Lasix




Primary Outcome Measures :
  1. Change from baseline in weight at the end of third week [ Time Frame: Baseline and at the end of the third week ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from baseline in serum sodium at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  3. Change from baseline in serum potassium at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  4. Change from baseline in blood urea nitrogen at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  5. 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 ]
  6. Change from baseline in serum albumin at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  7. Change from baseline in urine sodium at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  8. Change from baseline in urine potassium at the end of third week [ Time Frame: Baseline and at the end of the third week ]
  9. 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 ]
  10. 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 ]
  11. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427880


Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Mohammad Mahdi Sagheb, MD Nephrologist at Shiraz University of Medical Science

Publications:
Responsible Party: Mohammad Amin Fallahzadeh, MD-MPH, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02427880     History of Changes
Other Study ID Numbers: 7308
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016

Keywords provided by Mohammad Amin Fallahzadeh, Shiraz University of Medical Sciences:
Edema
Nephrotic syndrome
Acetazolamide
Furosemide

Additional relevant MeSH terms:
Hydrochlorothiazide
Edema
Nephrotic Syndrome
Nephrosis
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Furosemide
Acetazolamide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Potassium Chloride Symporter Inhibitors
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors