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CTRI Number  CTRI/2019/10/021791 [Registered on: 24/10/2019] Trial Registered Prospectively
Last Modified On: 20/08/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To determine the ideal maintenance fluid for critically ill children. 
Scientific Title of Study   COMPARISON OF 0.45% AND 0.9% SALINE IN 5% DEXTROSE AS MAINTENANCE FLUIDS IN CHILDREN ADMITTED WITH ACUTE ILLNESS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kumar Ratnjeet 
Designation  Post Graduate Student 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospitals. 
Address  301, Second floor,Type 2 quarters, Mirdard Lane
Maulana Azad Medical College and associated Lok Nayak Hospitals, Bahadur Shah Zafar Marg, Delhi - 110002
Central
DELHI
110002
India 
Phone  07838695570  
Fax    
Email  krat240@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr U Jhamb 
Designation  Director Professor and HoD of Pediatrics 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospitals. 
Address  Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospitals, 110002
Maulana Azad Medical College and associated Lok Nayak Hospitals, Bahadur Shah Zafar Marg, Delhi - 110002
Central
DELHI
110002
India 
Phone  9968604309  
Fax    
Email  ujhamb@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr U Jhamb 
Designation  Director Professor and HoD of Pediatrics 
Affiliation  Maulana Azad Medical College and associated Lok Nayak Hospitals. 
Address  Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospitals, Delhi 110002
Maulana Azad Medical College and associated Lok Nayak Hospitals, Bahadur Shah Zafar Marg, Delhi - 110002
Central
DELHI
110002
India 
Phone  9968604309  
Fax    
Email  ujhamb@hotmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Department of Pediatrics 
Address  Maulana Azad Medical College 
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 
Kumar Ratnjeet  Lok Nayak Hospitals  Department of Pediatrics, Lok Nayak and associated hospitals, Maulana Azad Medical College, Bahadur Shah Zafar Marg, Delhi-110002
Central
DELHI 		 07838695570

krat240@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R790||Abnormal level of blood mineral,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Fluid adminstration in critically ill Pediatric Patients  After chosing the patients according to exclusion criteria , two groups will be randomly selected. With a sealed envelope member of each group will be chosen. After that according to the group each one will be started with either 0.45% Normal Saline in 5% Dextrose or 0.9% Normal Saline in 5% Dextrose according to Holliday-Segars formula for a maximum duration of 3 days and then both the groups will be compared. 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All the children more than 3 months and less than 12 years of age requiring fluid management.
 
 
ExclusionCriteria 
Details  a) Children with age less than 3 months of age and more than 12 years of age.
b ) Children who have received more than 72 hours of intravenous fluid.
c) Children who are receiving drugs affecting sodium levels , i.e. Diuretics etc.
d) Children with Renal Disease ( AKI), Cardiac disease ( CHF) or Pituitary dysfunction , Diabetes mellitus.
e) Children with baseline sodium values, < 130 meq/dl and > 145 meq/dl.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of subjects developing hyponatremia after receiving designated fluid for the specified time.
 		 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in serum sodium levels from the baseline at 48,72 hours in whom iv fluids are continued.
2. Occurence of hyponatremia and hypernatremia. 		 72 hours 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
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)   23/11/2019 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details
Modification(s)  		 Not yet applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Hospital acquired acute Hyponatremia is increasingly recognised as the cause of morbidity and mortality in children. It has been attributed primarily to the use of hypotonic intravenous fluids to maintain fluid an electrolyte balance. The use of isotonic fluid (0.9% Normal Saline with 5% Dextrose) is recommended in most circumstances. Hypotonic intravenous fluids containing less than or equal to 0.45% NaCL shouldn’t be used to provide as a routine iv fluid maintenance requirement. 
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