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Completed

NCT Number: NCT02427880

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

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

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Key information

Conditions

Nephrotic Syndrome Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetazolamide and Hydrochlorothiazide Followed by Furosemide

Drug

Other names: Diamox Sequels and Microzide Followed by Lasix

Furosemide and Hydrochlorothiazide Followed by Furosemide

Drug

Other names: Lasix and Microzide Followed by Lasix

Primary outcomes

  1. Change from baseline in weight at the end of third week

    Time frame: Baseline and at the end of the third week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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