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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Nephrotic Syndrome (INS)
• Intervention / Treatment: Biological: Human Albumin 20%; Biological: Fresh Frozen Plasma

Detailed Description

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). Nephrotic syndrome is one of the most common pediatric renal diseases with an annual incidence of 1.2-16.9/100,000 children. It is characterized by edema, massive proteinuria (>40 mg/m2/h), and hypoalbuminemia (serum albumin <3 g/dL)(Kallash & Mahan, 2021). Edema affects the quality of life of pediatric patients with NS, even when it is only mild to moderate in severity, and this is especially seen in patients with steroid resistant NS. Albumin infusions can be a highly effective method to treat edema in patients with NS. Edema can develop in nephrotic syndrome, chronic kidney disease (CKD), heart failure, and liver cirrhosis. Usually, the patients with edema respond to dietary sodium restriction in combination with a loop diuretic. However, some patients become resistant to diuretics. Diuretic resistance is defined as the failure to achieve the therapeutically desired reduction in edema even when a maximal dose of diuretic is employed (Hoorn & Ellison, 2017).

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 (Bell & Mandalia, 2022). First-line management of edema involves sodium restriction and oral diuretics, most commonly loop diuretics like furosemide. However, a state of diuretic resistance often develops. This resistance is primarily due to two reasons reduced delivery: The hypoalbuminemia reduces the transport of furosemide to its site of action in the nephron, as the drug is highly protein-bound. Compensatory mechanisms are the intense activation of renin-angiotensin-aldosterone system and other neurohormonal pathways counteracts the natriuretic effect of diuretics, leading to rebound sodium retention (El-Halaby et al., 2022). 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. FFP cost half than albumin and same duration required to reduce edema but with double number of infusion and it is safe in pediatric patients with NS presenting with moderate to severe edema. The cost-effectiveness may place FFP as a better choice especially in developing countries of the world (Al Mamun et al., 2015).

Due to availability of limited local data, the aim of this randomized control trial study is to evaluate the efficacy of albumin versus fresh frozen plasma in managing diuretic resistant edema in children with idiopathic nephrotic syndrome in children's hospital and institute of child health Multan Punjab Pakistan, so that the overall morbidity and mortality due to NS can be reduced

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qamar Shafiq, MBBS; Phone Number: 00923076960500; Email: qamarshafiq710@gmail.com
• Study Contact Backup: Name: muhammad Asif, MBBS; Phone Number: 00923143329514; Email: asif18june@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: albumin; 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%; 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in serum albumin level	difference in serum albumin concentration measured before and after intervention in both study groups	baselines to 72 hours post intervention

Collaborators and Investigators

• Sponsor: Qamar Shafiq
• Collaborators: Children's Hospital and Institute of Child Health, Multan
• Investigators: Principal Investigator: Tariq aziz, MBBS FCPS, Children's Hospital and Institute of Child Health, Multan

Publications and helpful links

General Publications

• Kallash, M., & Maha

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): October 17, 2026
• Study Completion (Estimated): October 17, 2026

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: idiopathic nephrotic syndrome
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Nephrosis; Nephrosis, Lipoid
• Other Study ID Numbers: CHCMultan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data will not be shared publically only summarized results will be published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No