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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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