| 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
|
|
|
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
|
|
|
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. |