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CTRI Number  CTRI/2012/05/002637 [Registered on: 09/05/2012] Trial Registered Retrospectively
Last Modified On: 09/05/2012
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [intravenous maintenance fluids]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   a clinical trial to find the most appropriate maintenance fluid in children with central nervous system infection 
Scientific Title of Study   A randomized controlled trial of intravenous maintenance fluids ( isotonic vs hypotonic) in children with central nervous system infections.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
KSCH_LHMC  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ravitanaya Sodani 
Designation  MD (Pediatrics) Student 
Affiliation  Kalawati Saran Children;s Hospital, Lady Hardinge MedicalCollege, New Delhi 
Address  Department of Pediatrics, Kalawati Saran Children;s Hospital, Bangla Sahib marg, New Delhi
Department of Pediatrics, Kalawati Saran Children;s Hospital, Bangla Sahib marg, New Delhi
New Delhi
DELHI
110011
India 
Phone  09999796241  
Fax  0112365792  
Email  ravitanaya0808@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harish K Pemde 
Designation   
Affiliation  Professor - Pediatrics LHMC, New Delhi 
Address  Department of Pediatrics, LHMC
Kalawati Saran Childrens Hospital, Bangla Sahib Marg
New Delhi
DELHI
110001
India 
Phone  09868549681  
Fax  011-23365792  
Email  harishpemde@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harish K Pemde 
Designation   
Affiliation   
Address  Department of Pediatrics, LHMC
Kalawati Saran Childrens Hospital, Bangla Sahib Marg
New Delhi
DELHI
110001
India 
Phone  09868549681  
Fax  011-23365792  
Email  harishpemde@gmail.com  
 
Source of Monetary or Material Support  
No funding by any agency other than Kalawati saran Childrens Hospital, New Delhi. 
 
Primary Sponsor  
Name  Kalawati Saran Chiuldrens Hospital 
Address  Department of Pediatrics, Kalawati Saran Chiuldren;s Hospital, Lady Hardinge Medical College, Bangla Sahib Raod, New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Lady Hardinge Medical College New Delhi  Shaheed Bhagat Singh Marg, New Delhi 110001. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ravitanaya  Department of Pediatrics  Kalawati Saran Children Hospital , ,Bangla Saheb Marg-110001
New Delhi
DELHI 		 09999796241
011-23365792
ravitanaya0808@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
EthicalcommitteeofLadyhardingeMedicalCollegeNewDelhiIndia  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  to compare the incidence of hyponatremia with maintenance fluids ( isotonic and hypotonic) in children with CNS infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Maintenance fluid  Three arm subjects will receive oneo f the three types of maintenance fluid according to Holliday Segar formula for 24 hours 
Comparator Agent  maintenance fluids Norma Saline in 5% Dextrose, N/2 Saline in 5% Dextrose, N/5 Saline in 5% Dextrose  Arm-1 will get Norma Saline in 5% Dextrose, Arm2 will get N/2 Saline in 5% Dextrose, Arm3 will get N/5 Saline in 5% Dextrose. Volume will be calculated as per Holliday Segar Formula for atleast 24 hrs. 
 
Inclusion Criteria  
Age From  3.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  children of age 2month to 5 years with a clinical diagonosis of CNS infections requiring maintenance fluids for atleast 24 hrs 
 
ExclusionCriteria 
Details  -serum sodium less than 135 or more than 145 mmol/ L before starting maintenance fluids - previously diagonosed renal disease -documented cerebral salt wasting -hepatic failure with fluid retention -shock at presentation -diarrhoea -known endocrinal disorder(DI/IDDM/CAH) -severe malnutrition(asTBW in malnourished children is 70-80%as compared to 60% age matched well nourished controls) -DKA/cranioenchephalic trauma (at risk of cerebral edema)  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients developing hyponatremia(serum sodium 135mmol/L) after receiving intravenous maintenance fluids for atleast 24 hours.  24hrs 
 
Secondary Outcome  
Outcome  TimePoints 
1. serum sodium values at 6,12,18,24 hours of receiving maintenance fluids
 		 0,6,12,18,24 hrs 
prism III score  0 and 24 hrs 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   14/07/2010 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   part of MD pediatrics(2010-2011) thesis under delhi university 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This is a randomized control trial of intravenous maintenance fluids (isotonic versus hypotonic) in children with central nervous system infections to find whether isotonic maintenance fluid causes less hyponatremia in comparison to that caused by hypotonic maintenance fluid. In this study, children of 2 months to 5 years of age with suspected CNS infections will be enrolled and be given maintenance fluids (one of three i.e. N/5 saline in 5% Dextrose, 0.45 Normal Saline in 5% dextrose and 0.9 Normal Saline in 5%dextrose). Subject will be closely monitored clinically and blood samples will be taken for serum elelctrolytes and blood gas analysis. Serum sodium will be monitored at 6 12 18 and 24 hours. Incidence of hyponatremia and PRISM Score will be the outcome variables. This trial is likely to find appropriate maintenance fluid for children with CNS infections.
 
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