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CTRI Number  CTRI/2022/09/045700 [Registered on: 20/09/2022] Trial Registered Prospectively
Last Modified On: 24/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of furosemide alone and albumin-furosemide combination for treatment of edema in nephrotic syndrome children 
Scientific Title of Study   Comparison of furosemide infusion alone with albumin-furosemide combination for the treatment of refractory edema in children with nephrotic syndrome: a randomized controlled non-inferiority trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manish Kumar 
Designation  Professor 
Affiliation  Chacha Nehru Bal Chikitsalaya, Delhi 
Address  Chacha Nehru Bal Chikitsalaya, Delhi
Room no-403, Department of Pediatrics
East
DELHI
110095
India 
Phone  8595919318  
Fax    
Email  manishkp75@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Manish Kumar 
Designation  Professor 
Affiliation  Chacha Nehru Bal Chikitsalaya, Delhi 
Address  Chacha Nehru Bal Chikitsalaya, Delhi
Room no-403, Department of Pediatrics
East
DELHI
110095
India 
Phone  8595919318  
Fax    
Email  manishkp75@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Naman Kumar 
Designation  Post graduate student 
Affiliation  Chacha Nehru Bal Chikitsalaya, Delhi 
Address  Chacha Nehru Bal Chikitsalaya, Delhi
Chacha Nehru Bal Chikitsalaya, Department of Pediatrics, Delhi
East
DELHI
110031
India 
Phone  6207257213  
Fax    
Email  kumar.naman567@gmail.com  
 
Source of Monetary or Material Support  
Chacha Nehru Bal Chikitsalaya Delhi 
 
Primary Sponsor  
Name  Chacha Nehru Bal Chikitsalaya 
Address  Rajaram Kohli Marg, Geeta colony, Delhi 
Type of Sponsor  Government medical college 
 
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 
Manish Kumar  Chacha Nehru Bal Chikitsalaya  Department of Pediatrics, Emergency, OPD and pediatric wards
East
DELHI 		 8595919318

manishkp75@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC_CNBC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N040||Nephrotic syndrome with minor glomerular abnormality,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous 20% albumin-furosemide combination  Intravenous 20% human albumin 1 gm/kg over 2-4 hours followed by injection furosemide 2 mg/kg IV bolus at the end of albumin infusion for 3 consecutive days  
Intervention  Intravenous furosemide infusion alone   Intravenous furosemide bolus 2 mg/kg to achieve a steady state serum concentration, followed by IV furosemide infusion @ 0.5 mg/kg/hr for 12 hours for 3 consecutive days 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children, between 1-12 years of age, with nephrotic syndrome and refractory edema (<1% weight loss per day for 5 consecutive days or <5% cumulative weight loss by 5th day of hospitalization after receiving maximum oral dose of furosemide, hydrochlorothiazide or metolazone and IV furosemide bolus in sequence) will be enrolled for the study 
 
ExclusionCriteria 
Details  1.Known secondary causes of nephrotic syndrome or with features of glomerulonephritis; like gross hematuria, hypertension, oliguria and deranged kidney function.
2.Children with acute diarrhoea
3.Clinical features of hypovolemia
4.With AKI stage II or III according to KDIGO definition and classification criteria for AKI
5.Children with severe systemic infections; like pneumonia, peritonitis, cellulitis or sepsis
6.Children with respiratory distress
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the mean difference in percentage weight loss at 24 hours in children with nephrotic syndrome and refractory edema receiving furosemide infusion in comparison to those receiving albumin-furosemide combination   24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean difference in percentage weight loss between two groups.
 		 at 48 and 72 hours of therapy  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   01/10/2022 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Results will be published in a reputed journal 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This randomized controlled non-inferiority trial is aimed to demonstrate the noninferiority of furosemide infusion alone in comparison to albumin-furosemide combination in treatment of refractory edema in children with nephrotic syndrome. Children, between 1-12 years of age, with nephrotic syndrome and refractory edema (<1% weight loss per day for 5 consecutive days or <5% cumulative weight loss by 5th day of hospitalization after receiving maximum oral dose of furosemide, hydrochlorothiazide or metolazone and IV furosemide bolus in sequence) will be enrolled for the study. Primary objective of the study is to compare the percentage change in body weight after 24 hours of therapy in children with nephrotic syndrome having refractory edema receiving furosemide infusion alone with those receiving albumin-furosemide combination. Secondary objectives are- to compare urine output, urinary sodium excretion and hearing threshold at discharge between two groups. 

 
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