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Comparison of efficacy of furosemide alone and albumin-furosemide combination for treatment of edema in nephrotic syndrome children

Comparison of furosemide infusion alone with albumin-furosemide combination for the treatment of refractory edema in children with nephrotic syndrome: a randomized controlled non-inferiority trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045700
Enrollment
40
Registered
2022-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: N040- Nephrotic syndrome with minor glomerular abnormality

Interventions

Intervention1: Intravenous furosemide infusion alone: Intravenous furosemide bolus 2 mg/kg to achieve a steady state serum concentration, followed by IV furosemide infusion @ 0.5 mg/kg/hr for 12 hours

Sponsors

Chacha Nehru Bal Chikitsalaya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children, between 1-12 years of age, with nephrotic syndrome and refractory edema ( <1% weight loss per day for 5 consecutive days or <5% cumulative weight loss by 5th day of hospitalization after receiving maximum oral dose of furosemide, hydrochlorothiazide or metolazone and IV furosemide bolus in sequence) will be enrolled for the study

Exclusion criteria

Exclusion criteria: 1.Known secondary causes of nephrotic syndrome or with features of glomerulonephritis; like gross hematuria, hypertension, oliguria and deranged kidney function. 2.Children with acute diarrhoea 3.Clinical features of hypovolemia 4.With AKI stage II or III according to KDIGO definition and classification criteria for AKI 5.Children with severe systemic infections; like pneumonia, peritonitis, cellulitis or sepsis 6.Children with respiratory distress

Design outcomes

Primary

MeasureTime frame
To determine the mean difference in percentage weight loss at 24 hours in children with nephrotic syndrome and refractory edema receiving furosemide infusion in comparison to those receiving albumin-furosemide combinationTimepoint: 24 hours

Secondary

MeasureTime frame
1.Mean difference in percentage weight loss between two groups. Timepoint: at 48 and 72 hours of therapy

Countries

India

Contacts

Public ContactNaman Kumar

Chacha Nehru Bal Chikitsalaya, Delhi

manishkp75@yahoo.com8595919318

Outcome results

None listed

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