| CTRI Number |
CTRI/2012/04/002548 [Registered on: 09/04/2012] Trial Registered Retrospectively |
| Last Modified On: |
24/10/2013 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Comparing a lower dose of insulin with the standard dose of insulin for the treatment of children presenting with acute severe diabetes (Diabetic ketoacidosis) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL OF LOW DOSE (0.05 U/KG/HR) VERSUS STANDARD DOSE (0.1 U/KG/HR) INTRAVENOUS INSULIN INFUSION FOR THE TREATMENT OF DIABETIC KETOACIDOSIS IN CHILDREN |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthi N |
| Address |
Senior resident, Dept. Of Pediatrics,
Advanced pediatrics centre,
PGIMER,
Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9814376716 |
| Fax |
|
| Email |
karthinallasamy@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Jayashree |
| Address |
Dept. Of pediatrics,
Advanced pediatrics centre,
PGIMER,
Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Jayashree |
| Address |
Dept. Of pediatrics,
Advanced pediatrics centre,
PGIMER,
Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815594343 |
| Fax |
|
| Email |
mjshree@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Postgraduate Institute of Medical Education and Research (PGIMER) |
|
Primary Sponsor
Modification(s)
|
| Name |
Postgraduate Institute of Medical Education and Research PGIMER |
| Address |
Sector 12,
Chandigarh,
India - 160012. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthi N |
PGIMER |
Pediatric Emergency and Intensive care units,
Advanced pediatrics centre, PGIMER,
Chandigarh
|
9814376716
karthinallasamy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic ketoacidosis |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Regular Insulin |
Continuous intravenous insulin infusion (0.05 U/kg/hr) till the resolution of acidosis (pH 7.3; HCO3 15) |
| Comparator Agent |
Regular insulin |
Continuous intravenous insulin infusion(0.1U/kg/hr) till the resolution of acidosis (pH 7.3; HCO3 15) |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
all children aged 12 years and below presenting with diabetic ketoacidosis are enrolled |
|
| ExclusionCriteria |
| Details |
1.Features of cerebral edema at presentation
2.Received insulin infusion before admission
3.Features of sepsis at presentation
4.Anuria for more than 6 hours
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of fall in blood glucose |
till blood glucose falls to 250mg/dl |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of cerebral edema |
till the end point of study |
| incidence of hypoglycemia |
till the end point of study |
| incidence of hypokalemia |
till the end point of study |
| Rate of resolution of acidosis |
Till the end point of study |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
30/11/2011 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
Brief Summary
Modification(s)
|
This study is planned and being done as a Dissertation for the degree of D.M. (pediatric critical care) Rationale of the study: Guidelines recommend insulin infusion at 0.1U/kg/hr for the treatment of DKA. However even lower insulin doses are found to be effective in physiological and clinical studies for the resolution of ketoacidosis. Also, a lower dose can produce a slower rate of fall in blood glucose, thereby minimizing the risk of cerebral edema. The incidence of hypokalemia and hypokalemia during therapy can also be reduced with a lower dose of insulin. Hypothesis: Administration of Low dose insulin (0.05U/kg/hr) as compared to the standard dose (0.1U/kg/hr) for the treatment of diabetic ketoacidosis in children will not cause a decrease in the rate of fall in blood glucose of > 18mg/dl/hr. The primary objective of the study is to compare the rate of fall in blood glucose in two groups till the blood glucose value reaches to <250mg/dl. The secondary objectives being, to compare in the above groups, rate of resolution of acidosis, incidence of cerebral edema, incidence of hypokalemia and hypoglycemia. |
