Oral furosemide and hydrochlorothiazide/amiloride versus intravenous furosemide for the treatment of nephrotic edema

A prospective, randomized, unicentric study investigating the non-inferiority of combined oral diuretics furosemide and hydrochlorothiazide/amiloride to intravenous furosemide in patients with nephrotic edema and diuretic resistance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28785798

Enrollment

Registered

2020-12-29

Start date

2021-02-01

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diuretic treatment in nephrotic syndrome and diuretic-resistant edema Urological and Genital Diseases Nephrotic syndrome

Interventions

The study will include an estimated number of 20 patients, 10 patients in each treatment group. Patients will have a 24 h washout period with no diuretics administered and then, based on their FENa 5

<5 l/24 h - the same dose of 5 mg/h). Group 2 in which patients receive furosemide 40 mg/day and hydrochlorothiazide/amiloride 50 and 5 mg/day, respectively. Clinical and laboratory measurements wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years old 2. Nephrotic syndrome in patients without diabetes mellitus 3. Diuretic resistance 4. eGFR >30 ml/min/1.73 m²

Exclusion criteria

Exclusion criteria: 1. Age <18 years old 2. Nephrotic syndrome in patients with type 1 or type 2 diabetes 3. eGFR <30 ml/min/1.73 m² 4. Hypokalemia and hyperkalemia 5. Severe hyponatremia 6. Alcalosis 7. Severe pulmonary congestion 8. Active infection 9. NSAIDs use within the last month 10. Pregnancy 11. Kidney transplant 12. Known allergy to furosemide, hydrochlorothiazide or amiloride 13. Patients with a defibrillator/pacemaker/metal prosthesis

Design outcomes

Primary

Measure	Time frame
1. Weight measured at baseline and daily after randomization during the follow up period 2. Hydration status measured by bioimpedance at baseline and daily after randomization during the follow up period	—

Secondary

Measure	Time frame
1. Low blood pressure is established by daily measuring of blood pressure using a manual sphygmomanometer 2. Severe hyponatremia is established by daily measurement of serum sodium (blood test) 3. Hypokalemia and hyperkalemia is established by daily measurement of serum potassium (blood test) 4. Severe hypomagnesemia is established by daily measurement of serum magnesium (blood test) 5. Alcalosis is established by daily measurement of acid base balance (pH of venous blood gas sample) 6. Acute kidney injury is established by daily measurement of serum creatinine (blood test) and urinary output (over 24 h) 7. Aggravated hypervolemia at 3 days is established by fixed or increased body weight with clinical increased peripheral edema and urinary output <1.5 l/24 h	—

Measure

Time frame

1. Low blood pressure is established by daily measuring of blood pressure using a manual sphygmomanometer 2. Severe hyponatremia is established by daily measurement of serum sodium (blood test) 3. Hypokalemia and hyperkalemia is established by daily measurement of serum potassium (blood test) 4. Severe hypomagnesemia is established by daily measurement of serum magnesium (blood test) 5. Alcalosis is established by daily measurement of acid base balance (pH of venous blood gas sample) 6. Acute kidney injury is established by daily measurement of serum creatinine (blood test) and urinary output (over 24 h) 7. Aggravated hypervolemia at 3 days is established by fixed or increased body weight with clinical increased peripheral edema and urinary output <1.5 l/24 h

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026