| CTRI Number |
CTRI/2024/10/075558 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
New infections in patients admitted to hospital |
|
Scientific Title of Study
|
Hospital acquired infections in intensive care unit A retrospective study in a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Soumya MJ |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Rajarajeswari medical college and Hospital,Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya MJ |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Rajarajeswari medical college and Hospital,Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya MJ |
| Designation |
Professor |
| Affiliation |
Rajarajeshwari medical college and hospital |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital,Bangalore
Rajarajeswari medical college and Hospital,Bangalore
Bangalore Rural
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital,Bangalore,Karnataka -560074 |
|
|
Primary Sponsor
|
| Name |
Dr Soumya MJ |
| Address |
Department of Anaesthesiology,
Rajarajeswari medical college and Hospital, Bangalore,Karnataka-560074 |
| 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 Sowmya MJ |
Rajarajeswari Medical College and Hospital |
Room no:3, Department of Anaesthesiology,
Medical records department
Bangalore Rural
KARNATAKA |
09880574092
drsowmyamj80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajarajeswari medical college and hospital instituitional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with diagnosed hospital acquired infection cases in ICU during the time period from July first two thousand twenty to July thirtyfirst two thousand twenty four. |
|
| ExclusionCriteria |
| Details |
Patients whose case records are missing.
Patients whose case records are incomplete.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of hospital acquired infections in the ICU at a tertiary care hospital over four year period |
First day in ICU to last day in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the risk factors,causative organisms & outcomes of hospital acquired infections in the ICU |
First day in ICU to last day in ICU |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/10/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Nosocomial bacteraemia is a common complication in critical care patients which is mostly due to the invasive monitoring devices, CVCs, endotracheal intubation, use of urinary catheters . several preventive guidelines has been suggested and are being followed in the ICUs but still blood stream infections have a high prevalence leading to mortality and morbidity in ICU. Our study aims to identify the risk factors and causative organisms and take corrective measures based on the same. |