Comparison of Efficacy and Safety of Albumin Versus Fresh Frozen Plasma in Managing Diuretic Resistant Edema in Children With Idiopathic Nephrotic Syndrome.

Summary

Edema is a major component of nephrotic syndrome (NS), defined by Kidney Disease Improving Global Outcomes (KDIGO) guidelines is, urine protein/creatinine ratio ≥ 2 mg/mg, and hypoalbuminemia ≤ 2.5 g/dl). The causes of diuretic resistance include poor adherence to drug therapy or diet, pharmacokinetic issues, and compensatory sodium reabsorption. Impaired tubular secretion of diuretics is a common cause of diuretic resistance. The cornerstone of managing diuretic resistance is breaking the pathophysiological cycle. Fresh Frozen Plasma (FFP) is a viable, cost-effective alternative to intravenous albumin for managing diuretic resistant edema in children with idiopathic nephrotic syndrome (INS) but it may require more infusions than albumin.

The main purpose of the study is to compare the albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome The duration of study is six months after approval of synopsis. The study will be conducted in indoor Department of pediatric nephrology department, The Children's Hospital \& the Institute of Child Health, Multan. A sample size of 56 patients will be included in the study. Informed consent will be taken from included patients. The Group-A study population will be with intravenous albumin, 1 gm/kg/day in single daily dose over 4 hours followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be with intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg. Primary outcomes will be response to treatment in form of resolution of clinical signs within 72 hours of treatment. Secondary outcomes will be duration of hospital stay, mortality, complication of treatment, complications of disease and hearing assessment.

Data will be analyzed through SPSS v23. For quantitative variables, the mean standard deviation will be calculated and for qualitative variables, frequency and percentage will be calculated. This study will provide a better opportunity to study Albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in The Children's Hospital \& the Institute of Child Health, Multan

Conditions

• Idiopathic Nephrotic Syndrome (INS)

Interventions

BIOLOGICAL

Human Albumin 20%

The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg

BIOLOGICAL

Fresh Frozen Plasma

The Group-A study population will be given intravenous albumin, 1 gm/kg/day over 4 hours in single daily dose followed by intravenous furosemide 1 mg/kg/day. Salt poor 20% human albumin will be administered which will be osmotically equivalent to 200ml of plasma. The Group-B study population will be given intravenous FFP 15ml/kg/day over 2 hours followed by intravenous furosemide 1 mg/kg

Sponsors & Collaborators

• Children's Hospital and Institute of Child Health, Multan

  collaborator OTHER_GOV

• Qamar Shafiq

  lead OTHER_GOV

Principal Investigators

• Tariq aziz, MBBS FCPS · Children's Hospital and Institute of Child Health, Multan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-05

Primary Completion

2026-10-17

Completion

2026-10-17