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CTRI Number  CTRI/2019/02/017705 [Registered on: 18/02/2019] Trial Registered Prospectively
Last Modified On: 29/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare Normal Saline and Ringers Lactate for fluid therapy in children with diabetic ketoacidosis 
Scientific Title of Study   Normal Saline versus Ringers Lactate for intravenous fluid therapy in children with diabetic ketoacidosis : A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devanshi Singhal 
Designation  1st Year Post Graduate Student 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Room No 316 RMO Hostel A 33, Bangla Sahib Rd, Block 85, DIZ Area, Gole Market, New Delhi, Delhi 110001

New Delhi
DELHI
110001
India 
Phone  9899687871  
Fax    
Email  devanshi_singhal@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalu Gupta 
Designation  Professor 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Kalawati Saran Childrens Hospital C-604 Shaheed Bhagat Singh, Road, DIZ Area, Connaught Place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9779577087  
Fax    
Email  sguptabhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Devanshi Singhal 
Designation  1st Year Post Graduate Student 
Affiliation  Lady Hardinge Medical College and Associated Hospitals 
Address  Room No 316 RMO Hostel A 33, Bangla Sahib Rd, Block 85, DIZ Area, Gole Market, New Delhi, Delhi 110001

New Delhi
DELHI
110001
India 
Phone  9899687871  
Fax    
Email  devanshi_singhal@yahoo.co.in  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and Associated Hospitals C-604 Shaheed Bhagat Singh, Road, DIZ Area, Connaught Place, New Delhi, Delhi 110001 
 
Primary Sponsor  
Name  Dr Devanshi Singhal 
Address  Room No 316 RMO Hostel A 33, Bangla Sahib Rd, Block 85, DIZ Area, Gole Market, New Delhi, Delhi 110001 
Type of Sponsor  Other [Self] 
 
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 
Dr Devanshi Singhal  Kalawati Saran Childrens Hospital  Kalawati Saran Childrens Hospital C-604 Shaheed Bhagat Singh, Road, DIZ Area, Connaught Place, New Delhi, Delhi 110001
New Delhi
DELHI 		 9899687871

devanshi_singhal@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E101||Type 1 diabetes mellitus with ketoacidosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal Saline  Intravenous fluid therapy based on percentage of assumed dehydration and maintenance 
Intervention  Ringers Lactate  Intravenous fluid therapy based on percentage of assumed dehydration and maintenance 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Case definition for diabetic ketoacidosis has been taken as random blood glucose more than 200mg/dL, venous pH less than 7.3 or serum bicarbonate less than 15mmol/L and blood ketones more than or equal to 3mmol/L or moderate or large ketonuria 
 
ExclusionCriteria 
Details  Children who have received partial treatment or fluid boluses from outside
Children with serum sodium less than 135 mEq/L
Children with serum potassium more than 5.5 mEq/L 
 
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 
Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groups  Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groups 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients developing acute renal injury  48 hours 
Time taken for normalization of anion gap and blood glucose  48 hours 
Time taken to change type of fluid  48 hours 
Total amount of fluid and insulin administered  48 hours 
Total length of stay in PICU   4 days 
Total length of stay in the hospital  2 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/02/2019 
Date of Study Completion (India) 31/03/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 This is a triple blind randomized controlled trial comparing the efficacy of Ringer’s Lactate and Normal Saline for intravenous fluid therapy in 50 children with diabetic ketoacidosis, 25 children in each group. The study will be conducted in Kalawati Saran Children’s Hospital, New Delhi, India.The primary outcome measure will be time taken for resolution of acidosis ie venous pH more than or equal to 7.3 in both groups. Secondary outcome measures will be proportion of patients developing acute renal injury within the study period, time taken for normalization of anion gap and blood glucose, time taken to change type of fluid, total amount of fluid and insulin administered and total length of stay in PICU and in the hospital. 
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