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

NCT07685093 | Not Yet Recruiting DMC

• 1 other identifier: CHCMultan
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

idiopathic nephrotic syndrome

Outcome Measures

Primary Outcomes (2)

• time to resolution of edema

  primary outcome is time required to achieve clinically significant resolution of edema

  baselines to 72 hours post intervention

• Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment

  Primary outcomes will be response to treatment in form of resolution of clinical signs within 24 to 48 hours of treatment

  24 to 48 hours

Secondary Outcomes (1)

• change in serum albumin level

  baselines to 72 hours post intervention

Study Arms (2)

albumin

EXPERIMENTAL

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: Human Albumin 20%; Biological: Fresh Frozen Plasma

fresh frozen plasma

ACTIVE COMPARATOR

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: Human Albumin 20%; Biological: Fresh Frozen Plasma

Interventions

Human Albumin 20% BIOLOGICAL

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

albumin; fresh frozen plasma

Fresh Frozen Plasma BIOLOGICAL

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

albumin; fresh frozen plasma

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children diagnosed with an idiopathic nephrotic syndrome and diuretic resistant as per the definition • Children of either gender. • Children of 2-12 years of age

You may not qualify if:

• Patients with secondary nephrotic syndrome/heart failure/hepatic dysfunction/severe renal impairment • Children with severe sepsis/hemodynamically unstable. • Children who had recent exchange transfusion • Parents refused to follow up

Sponsors & Collaborators

• Qamar Shafiq: lead
• Children's Hospital and Institute of Child Health, Multan: collaborator

Related Publications (1)

• Kallash, M., & Maha

  BACKGROUND

Related Links

• the description of refrences briefly explain the purpose and relevance of the cited literature in supporting the study background and rationale.

MeSH Terms

Conditions

Nephrosis, Lipoid

Condition Hierarchy (Ancestors)

Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tariq aziz, MBBS FCPS

  Children's Hospital and Institute of Child Health, Multan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qamar Shafiq, MBBS

CONTACT

00923076960500; qamarshafiq710@gmail.com

muhammad Asif, MBBS

CONTACT

00923143329514; asif18june@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: this isan open lable study with no blinding .both investigatotrs and participant are aware of assigned intervention due to distinct nature of treatment and practical limitations in masking blood product adminstration in a clinical setting
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: post graduate resident

Model Details: albumin vs fresh frozen plasma in diuretic resistent edema in idiopathic nephrotic syndrome

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: July 6, 2026
• Study Start: July 5, 2026
• Primary Completion (Estimated): October 17, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share