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Comparison of fast and slow albumin infusion in terms of effectiveness and safety in children with nephrotic syndrome and edema.

Efficacy and safety of albumin infusion over one hour versus four hours in children with nephrotic syndrome with edema and hypovolemia: An open-label randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102867
Enrollment
56
Registered
2026-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: N041- Nephrotic syndrome with focal andsegmental glomerular lesions

Interventions

Intervention1: 20% human albumin over one hour: In children with nephrotic syndrome with edema and hypovolemia, 20% human albumin infusion will be given over one hour. Control Intervention1: 20% human

Sponsors

AIIMS NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Nephrotic syndrome with relapse and edema and hypovolemia (as per SSNS guidelines)

Exclusion criteria

Exclusion criteria: 1. Shock (Systolic blood pressure less than 5th centile) 2. Anuria more than 24 hours 3. Use of furosemide in last 12 hours 4. Evidence of hypervolemia (elevated JVP, bilateral crepitations, tender hepatomegaly) • Pneumonia • Spontaneous bacterial peritonitis • Sepsis (defined by suspected infection and Phoenix score greater than 2) • Refusal of consent • Previously enrolled patient

Design outcomes

Primary

MeasureTime frame
To compare urine output at 6 hours after initiating therapy with 20% albumin infusion given over 1 hour versus 4 hours in children with nephrotic syndrome, aged 3 to 18 years, with edema and hypovolemia.Timepoint: To compare urine output at 6 hours after initiating therapy with 20% albumin infusion—

Secondary

MeasureTime frame
Change in hematocrit at 1, 4 and 6 hours. Percentage weight loss and natriuresis over 12 hours from initiation of therapy. Free water excretion over 6 hours. Change from baseline at 6 hours in: serum albumin, sodium, potassium and bicarbonate. Change in urine and serum osmolality from baseline to 6 hours Change in IVCI and IVCCI from baseline to 6 hours Inferior vena cava index: Diameter of IVC/Body surface area Inferior vena cava collapsibility index: (Maximum diameter â?? Minimum diameter) x 100/Maximum diameter Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) and serious AE (SAE)Timepoint: ;1. Change in hematocrit 2. Percentage weight loss & natriuresis 3. Free water excretion 4. Change in: serum albumin, sodium, potassium & bicarbonate 5. Change in urine & serum osmolality 6. Change in IVCI & IVCCI Inferior vena cava index: Diameter of IVC/Body surface area Inferior vena cava collapsibility index: (Maximum diameter â?? Minimum diameter) x 100/Maximum diameter 7. Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) & serious AE (SAE)Timepoint: 1. 1, 4 & 6 hours. 2. At baseline & 12 hours 3. Over 6 hours 4. At baseline & 6 hours 5. At baseline & 6 hours 6. At baseline & 6 hours 7. Over 12 hours—

Countries

India

Contacts

Public ContactDr Pankaj Hari

AIIMS, New Delhi

pankajhari@hotmail.com09560701175

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026