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CTRI Number  CTRI/2026/02/102867 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 20/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of fast and slow albumin infusion in terms of effectiveness and safety in children with nephrotic syndrome and edema.  
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Hari 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  09560701175  
Fax    
Email  pankajhari@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Hari 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 815, Department of pediatrics, Mother Child block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  09560701175  
Fax    
Email  pankajhari@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Hari 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 815, Department of pediatrics, Mother Child block, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  09560701175  
Fax    
Email  pankajhari@hotmail.com  
 
Source of Monetary or Material Support  
AIIMS, NEW DELHI 110029 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  AIIMS, Ansari Nagar, New Delhi 110029, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ADIBA  AIIMS  Department of Pediatrics, AIIMS, Ansari Nagar, New Delhi
South
DELHI 		 8506843737

adibashakeel18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N041||Nephrotic syndrome with focal andsegmental glomerular lesions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  20% human albumin over 4 hours  In children with nephrotic syndrome with edema and hypovolemia, 20% human albumin infusion will be given over four hours. 
Intervention  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. 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Nephrotic syndrome with relapse and edema and hypovolemia (as per SSNS guidelines)
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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.  To compare urine output at 6 hours after initiating therapy with 20% albumin infusion 
 
Secondary Outcome  
Outcome  TimePoints 
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 – Minimum diameter) x 100/Maximum diameter
Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) and serious AE (SAE) 		  
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 – Minimum diameter) x 100/Maximum diameter
7. Rates, severity (CTCAE), relatedness to therapy (WHO-UMC) of adverse events (AE) & serious AE (SAE) 		 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 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
This study aims to assess efficacy of albumin infusion over one hour versus 4 hours in increasing urine output over 6 hours from initiation of therapy in nephrotic syndrome children, aged 3 to 18 years, with edema and hypovolemia. Rationale behind the study is that rapid albumin infusion leads to higher plasma volume expansion which may help in early restoration of circulatory volume in hypovolemic patients and hence may augment diuresis. Rapid albumin infusion has also shown to increase the half-life of albumin. While studies have shown better efficacy with albumin infusion in children with nephrotic syndrome when given along with diuretics, the safety of albumin infusion given over 1 hour is not well documented.
The pharmacokinetics of albumin may vary in children with nephrotic syndrome due to ongoing proteinuria in relapse state. Data suggests better efficacy of rapid albumin infusion in healthy
individuals but there is dearth of data in children with nephrotic syndrome comparing fast and slow albumin infusions in terms of safety and efficacy. Hence, we aim to compare albumin infusion over 1 hour versus 4 hours.
Patients fulfilling inclusion criteria will be stratified based on biochemical or clinical evidence of hypovolemia and will be randomised to receive 20% albumin infusion either over 1 hour or 4 hours. Patients will be assessed for urine output over 6 hours from initiating the therapy and they will be monitored for any adverse events.
 
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