| CTRI Number |
CTRI/2020/11/028825 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefits of vitamin thiamine, vitamin C,vitamin B12 in children with severe infection - RCT |
|
Scientific Title of Study
|
Randomised control study - To study effect of metabolic resuscitation with thiamine & vitamin C, B12 in pediatric severe sepsis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
drparag shankar rao dekate |
| Designation |
Consultant pediatric intensivist |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
PICU,Rainbow childrens hospital,ROAD2,BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
7506866005 |
| Fax |
|
| Email |
paggy4u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrParag shankarao dekate |
| Designation |
PICU CONSULTANT |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
PICU, Rainbow childrens hospital,ROAD 2, BANJARA HILLS, HYDERABAD,TELANGANA
Hyderabad
TELANGANA
500034
India |
| Phone |
9592026143 |
| Fax |
|
| Email |
paggy4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrLSuman |
| Designation |
PICU DNB SS Resident |
| Affiliation |
RAINBOW CHILDRENS HOSPITAL |
| Address |
PICU,Rainbow childrens hospital,ROAD 2, BANJARA HILLS, HYDERABAD,TELANGANA
Block 3B, 504, SMR Vinay fountain head appartments, hydernagar, hyderabad, telangana
Hyderabad
TELANGANA
500034
India |
| Phone |
9592026143 |
| Fax |
|
| Email |
lsumanpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rainbow childrens hospital |
| Address |
Road no 2, Banjara hills, hyderabad |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrLSuman |
Pediatric intesive care unit, Rainbow childrens hospital, banjara hills |
Banjara hills, road 2, hyderabad
Hyderabad
TELANGANA |
9592026143
lsumanpgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow hospital institutional ethics comitte |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Thiamine, Injection Vitamin C, Injection vitamin B12 |
Injection thiamine 100mg iv BD, injection Vitamin C 30mg/kg IV QID, injection vitamin B12 1000mcg IV od FOR 3 days |
| Comparator Agent |
STANDARD PICU treatments as per protocol |
Standard treatment as per PICU PROTOCOL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All Cases of Severe sepsis and septic shock will be categorised to study grup and control group. Study group will receive inj Thiamine, vitamin C, Vitamin B12 along with standard treatment as per PICU protocol. Control group would receive only standard treatment as per PICU protocol |
|
| ExclusionCriteria |
| Details |
KNOWN CASE OF VITAMIN C,THIAMINE, B12 Deficiency
cases of dilated cardiomyopathy
INBORN ERROR OF METABOLISM
RENAL STONES
ALLERGY TO VITAMIN C, THIAMINE, B12 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality Benefits |
Mortality Benefits |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lactate levels,
SOFA Scores
VIS Scores,
Length of PICU stay and hospital stay |
5 Days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/11/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All cases of pediatric severe sepsis and septic shock patients are randomised to study group and control group. Study group would receive Inj thiamine,inj Vitamin C, Inj Vitamin B12 for 3 days along with standard treatment as per PICU protocol and control group would receive only standard treatment as per PICU protocol. Multiple variants including mortality benefits, SOFA score,VIS score, lactate levels , duration of hospital stay will be compared among the study and control groups. |