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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
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Edema, Nephrotic syndrome, Acetazolamide, Furosemide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    April 20, 2015
    Last Updated
    February 21, 2016
    Sponsor
    Shiraz University of Medical Sciences
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    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

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

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