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A clinical study comparing the effect of protein solution with diuretic drug against diuretic drug alone in sick protein-deficient children with excessive body water

Albumin with Furosemide vs Furosemide Alone in Critically-ill Hypoalbuminemic Children with Fluid Overload - A Pilot Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010247
Enrollment
50
Registered
2017-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Critically ill Mechanically ventilated Hypoalbuminemic Children with Fluid Overload

Interventions

Intervention1: Albumin with furosemide: 20% albumin 5ml/kg iv infusion over 6hours with furosemide 0.05-0.2 mg/kg/hr iv infusion for 48hours Control Intervention1: Normal saline with furosemide: norma

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PICU stay > 48 hours Age 2 month to 12 years Mechanically ventilated Presence of fluid overload Decision by the treatment physician to achieve diuresis Hypoalbuminemia (serum albumin

Exclusion criteria

Exclusion criteria: Hemodynamic instability at the time of recruitment or during preceding 12 hours Children with severe acute malnutrition, cardiac disease, renal failure, liver failure, nephrotic syndrome or protein losing enteropathy Receipt of albumin transfusion in preceding 48 hours Receipt of furosemide in the preceding 12 hours History of adverse reaction to prior albumin transfusion Hemoglobin Serum Na+ > 155mEq/l and cannot be corrected prior to enrollment Serum K+

Design outcomes

Primary

MeasureTime frame
ventilator free daysTimepoint: ventilator free days

Secondary

MeasureTime frame
All-cause 28-day mortality Length of PICU stay Length of hospital stay among survivors Incidence of new onset/ progression of MODS Duration of furosemide infusion Need for dialysis at 28 days Number of adverse events related to study intervention Timepoint: 28 days

Countries

India

Contacts

Public ContactDr V Mounika Reddy

PGIMER, Chandigarh

ny.karthi@gmail.com9855784739

Outcome results

None listed

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