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CTRI Number  CTRI/2018/06/014472 [Registered on: 08/06/2018] Trial Registered Prospectively
Last Modified On: 07/06/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Other (Specify) [Route of fluid correction for dehydration in diabetic ketoacidosis]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to understand whether treatment with oral fluid therapy is better than or as good as treatment with intravenous fluid therapy in treatment of dehydration at pH values greater than or equal to 7.25 during treatment of dehydration in diabetic ketoacidosis in children. 
Scientific Title of Study   Comparison of efficacy of oral versus intravenous fluid therapy during the correction of dehydration in children with diabetic ketoacidosis once the pH is ≥ 7.25: an open label randomized controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kola Shourya Vijay Tej 
Designation  Post graduate student 
Affiliation  LHMC and Kalawati Saran Childrens Hospital, Delhi  
Address  Department of Paediatrics LHMC and Kalawati Saran Children Hospital Delhi

Central
DELHI
110001
India 
Phone  9489955569  
Fax    
Email  ksvtej@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Virendra Kumar 
Designation  Head Of Department 
Affiliation  LHMC and Kalawati Saran Childrens Hospital, Delhi  
Address  Department of Paediatrics LHMC and Kalawati Saran Children Hospital Delhi

Central
DELHI
110001
India 
Phone  9489955569  
Fax    
Email  drvkumar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kola Shourya Vijay Tej 
Designation  Post graduate Junior resident 
Affiliation  LHMC and Kalawati Saran Children Hospital, Delhi  
Address  Department of Paediatrics LHMC and Kalawati Saran Children Hospital Delhi

Central
DELHI
110001
India 
Phone  9489955569  
Fax    
Email  ksvtej@gmail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and Kalawati Saran Childrens hospital,C- 604, Connaught Circus, DIZ Area, Connaught Place, New Delhi, Delhi 110001 
 
Primary Sponsor  
Name  Kola Shourya Vijay Tej 
Address  Department of Paediatrics LHMC and Kalawati Saran Children Hospital Delhi  
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 
Kola Shourya Vijay Tej  Lady Hardinge Medical College and Kalawati Saran Children Hospital  Department of Paediatrics/Pediatric Critical Care Unit,Ground floor, Room 22
Central
DELHI 
9489955569

ksvtej@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ,Lady Hardinge Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients having diabetic ketoacidosis in paediatric age group,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous Fluid therapy  Fluid will be given on a hourly basis - frequency for a duration of 48 hrs. total fluid to be given over 48 hrs will be including both dehydration deficit correction and maintenance correction as per ISPAD guidelines. Intravenous Fluid will be continued to be given as per standard guidlines that is ISPAD guidlines -international society for pediatric and adolescent diabetes  
Intervention  Oral Fluid Thaerapy  Fluid therapy will be calculated for hourly basis - frequency and will be given for a total duration of 48 hours. Oral fluid will be given once resolution of acidosis has started using blood gas analysis that is at stage after pH equal or beyond 7.25 and with GCS equal or beyond 12 ,then remaining fluid requirement estimated for 48 hours will be continued to be given orally till the end of 48 hours . Fluid therapy be will calculated for a duration of 48 hrs that is dehydration correction and maintenance correction.  
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All Children of age less than 18 years fulfilling the case definition of diabetic ketoacidosis who present to pediatric emergency as per ISPAD guidlines -International society for pediatric and adolescent diabetes 
 
ExclusionCriteria 
Details  Children who fail to achieve a pH≥7.25 or fail to achieve a GCS >12 or children with a falling GCS by two points from baseline.
Children admitted with DKA and who are partially treated in outside hospital.
Children with co-morbidities where fluid therapy cannot be altered.
Children with comorbidities which contraindicate oral feed.
Children whose parents are not willing to consent. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proprortion of children having successful hydration correction at the end of 48 hrs in both groups.  from time of initiation of therapy to end of 48 hours of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
Comparative analysis of time taken by intravenous fluid versus oral fluid therapy after resolution of acidosis pH ≥ 7.25 in DKA to complete normalization of pH, bicarbonate, and ketonuria   from time of initiation of therapy to end of 48 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   N/A 
Date of First Enrollment (India)   20/06/2018 
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="9"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

A clinical trial to compare the efficacy of oral fluid versus intravenous fluid therapy for correction of dehydration at pH values ≥7.25 during therapy of DKA in children. Standard Protocols based on data from developed countries followed globally like Milwaukee Protocol and ISPAD consensus 2014 suggest fluid deficit correction at variable intervals over 24 hours and 48 hours respectively which show a 24 hour difference in fluid deficit correction. In a study of 635 episodes of DKA the mean time to correction of DKA and complete restoration of the circulation was 11.6 ± 6.2 h. There is a need for fluid trials for the early initiation of oral hydration therapy which may reduce overcorrection and its complication. Hypothesis of  the study is that after the resolution of acidosis state to a pH≥7.25(mild DKA), hydration of the child will be adequately improved, then remaining fluid replacement can be managed with oral hydration therapy instead of intravenous fluid hydration therapy; which will prevent overzealous hydration and its complications. Ongoing evaluation for resolution of acidosis using blood gas analysis will be done. Randomization done at stage after pH ≥ 7.25 and with GCS >12. The study is being done to observe the proprortion of children having successful hydration correction at the end of 48 hrs in both groups. To comparatively analyze the time taken by intravenous fluid versus oral fluid therapy after resolution of acidosis pH ≥ 7.25 in DKA to complete normalization of pH, bicarbonate, and ketonuria. Then further analysis will allow to compare the efficacy of oral fluid versus intravenous fluid therapy for correction of dehydration at pH values ≥7.25 during therapy of  diabetic ketoacidosis in children.

 
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