| CTRI Number |
CTRI/2018/12/016634 [Registered on: 12/12/2018] Trial Registered Prospectively |
| Last Modified On: |
11/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To test the effectiveness of Vitamin C to decrease pneumonia in mechanically ventilated patients |
|
Scientific Title of Study
|
A Randomized controlled trial to examine the usefulness of Vitamin C to reduce incidence of Ventilator associated pneumonia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chinmaya Joshi |
| Designation |
Doctor |
| Affiliation |
St, Stephens Hospital, Delhi |
| Address |
C 5-1, R. K. Puram Sector 13, MS Flats
New Delhi
DELHI
110066
India |
| Phone |
8929342448 |
| Fax |
|
| Email |
chinmayajoshi1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jacob M Puliyel |
| Designation |
Head of department of Pediatrics |
| Affiliation |
St. Stephens Hospital |
| Address |
Tis Hazari, Delhi
North
DELHI
110054
India |
| Phone |
9868035091 |
| Fax |
|
| Email |
puliyel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jacob M Puliyel |
| Designation |
Head of department of Pediatrics |
| Affiliation |
St. Stephens Hospital |
| Address |
Tis Hazari, Delhi
North
DELHI
110054
India |
| Phone |
9868035091 |
| Fax |
|
| Email |
puliyel@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
St Stephens Hospital |
| Address |
Tis Hazari, Delhi |
| 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 |
| DR CHINMAYA JOSHI |
ST. STEPHENS HOSPITAL |
Pediatric HDU, Department of Pediatrics and Neonatology
Tis Hazari
North
DELHI |
8929342448
chinmayajoshi1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| St. Stephens ethical committee |
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, (2) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Vitamin C and placebo |
Cases to be given Vitamin c and controls to be given placebo |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All patients ventilated on day 1 of hospitalisation |
|
| ExclusionCriteria |
| Details |
All patients ventilated in other hospital and then referred |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the usefulness of Vitamin C to reduce incidence of Ventilator associated pneumonia. |
The time to development of polymorphic cell reaction and time to development of CDC criteria for VAP will be examined in both case and control groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of ventilation and hospitalization will be recorded. |
Duration of ventilation and hospitalization |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/12/2018 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study is to
examine the usefulness of Vitamin C to reduce incidence of Ventilator
associated pneumonia in patients admitted to Pediatric HDU
at St. Stephen’s Hospital. The time to development of polymorphic cell reaction
and time to development of VAP will be examined in both test and control
groups. Also duration of ventilation and hospitalization will be recorded. As there has been no previous study of
use of vitamin C as a mucolytic in ventilated patients, we propose to do a
pilot study taking a sample size of 40 patients of which 20 will be cases and
20 controls. The effect size and variance in this group will be studied to help
in sample size calculations for a definitive study if this sample size proved
inadequate. The
patient randomised to receive vitamin C will be the test group. The other group
receiving standard care will be controls. Prophylactic doses of vitamin C at a
dose of 40 mg per kg will be given to the cases from the time of intubation and
comparisons will be made to the control
group receiving standard therapy.ET
secretions will be examined every day looking for polymorphonuclear cells on
microscopy. Secretions with raised counts will be sent for microbiological
evaluation – staining for bacteria and for culture of organisms. |