CTRI Number |
CTRI/2019/01/017321 [Registered on: 31/01/2019] Trial Registered Prospectively |
Last Modified On: |
29/12/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
cohort and case control |
Study Design |
Other |
Public Title of Study
|
Causes for developing bacteremia in mechanically ventilated patients |
Scientific Title of Study
|
Risk factors for bacteremia in patients with ventilator associated pneumonia, a cohort with a nested case control study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Anisha Umashankar |
Designation |
Junior resident |
Affiliation |
Kasturba Medical College, manipal |
Address |
Department of General Medicine,
Kasturba Medical College,
Manipal
Udupi KARNATAKA 576104 India |
Phone |
9986821460 |
Fax |
|
Email |
anishau103@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Muralidhar Varma |
Designation |
Assistant professor |
Affiliation |
Kasturba Medical College, manipal |
Address |
Department of General Medicine,
Kasturba Medical College,
Manipal
Udupi KARNATAKA 576104 India |
Phone |
9845069639 |
Fax |
|
Email |
drmuralidharvarma@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Anisha Umashankar |
Designation |
Junior resident |
Affiliation |
Kasturba Medical College, manipal |
Address |
Department of General Medicine,
Kasturba Medical College,
Manipal
Udupi KARNATAKA 576104 India |
Phone |
9986821460 |
Fax |
|
Email |
anishau103@gmail.com |
|
Source of Monetary or Material Support
|
Kasturba Medical College Manipal |
|
Primary Sponsor
|
Name |
Anisha Umashanakar |
Address |
Department of general medicine, Kasturba medical college, Manipal, Karnataka, India |
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 |
Dr Anisha Umashankar |
Kasturba Hospital |
Department of Medicine, Kasturba Medical College, Manipal, Udupi, Karnataka
576104 Udupi KARNATAKA |
9986821460
anishau103@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kasturba medical college and Kasturba hospital Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J95-J95||Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
patients who develop ventilator associated pneumonia as defined as, when in a mechanically ventilated patient has:
1. new persistent pulmonary infiltrates not otherwise explained
2. purulent respiratory secretions
3. systemic signs of inflammation |
|
ExclusionCriteria |
Details |
-inclusion criteria not met
-patients in surgical ICUs |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To identify the bacteria and the risk factors causing ventilator associated pneumonia (VAP). To reveal the faults in the CDC defined surveillance for VAP as compared to the clinical definition of VAP. |
patient will be assessed at the time of admission and at the time of discharge or death |
|
Secondary Outcome
|
Outcome |
TimePoints |
To reveal the faults in the CDC defined surveillance for VAP as compared to the clinical definition of VAP. |
2 years |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
10/02/2019 |
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="8" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
not applicable |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
My study is an
observational study, on patients who develop Ventilaor associated pneumonia (VAP) that I will be following up.
It involves collecting appropriate data from the patients that develop VAP and
see which patients develop bacteraemia and the probable risk factors for it.
Therefore patients who are admitted in any of the Medical ICUs in the hospital,
requiring ventilator assistance in any form, who develop VAP according to the inclusion criteria will be included
in my study. Data about the patients will be collected after taking informed
consent. Information as per my proforma will be collected from these patients
such as ventilator settings, radiological, microbiological and biochemical will
be collected. These patients will be followed up.
The data collected from these patients will then be compared. Patients
with VAP who develop bacteremia will become cases and those who do not will
become controls. The data will then be compared, matched and analyzed
accordingly. No active intervention will be done during this study. |