| CTRI Number |
CTRI/2025/05/087305 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of clinical profile and outcome of ICU patients with community acquired severe infection in pre and post COVID 19 era |
|
Scientific Title of Study
|
Comparison of clinical profile and outcome of patients admitted in ICU with CAS in pre and post COVID era |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahuya Bhattacharyya |
| Designation |
Consultant, Dept Of Critical Care |
| Affiliation |
Manipal Hospital(Former AMRI Hospital) |
| Address |
C.I.T Scheme, Gariahat Rd, Dhakuria, LXXII Block A, P-4 and 5, Kolkata, West Bengal 700029
Kolkata
WEST BENGAL
700029
India |
| Phone |
|
| Fax |
|
| Email |
mohua20002000@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahuya Bhattacharyya |
| Designation |
Consultant, Dept Of Critical Care |
| Affiliation |
Manipal Hospital (Former AMRI Hospital) |
| Address |
C.I.T Scheme, Gariahat Rd, Dhakuria, LXXII Block A, P-4 and 5, Kolkata, West Bengal 700029
Kolkata
WEST BENGAL
700029
India |
| Phone |
|
| Fax |
|
| Email |
mohua20002000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahuya Bhattacharyya |
| Designation |
Consultant, Dept Of Critical Care |
| Affiliation |
Manipal Hospital (Former AMRI Hospital) |
| Address |
C.I.T Scheme, Gariahat Rd, Dhakuria, LXXII Block A, P-4 and 5, Kolkata, West Bengal 700029
Kolkata
WEST BENGAL
700029
India |
| Phone |
|
| Fax |
|
| Email |
mohua20002000@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Hospitals |
| Address |
C.I.T Scheme, Gariahat Rd, Dhakuria, LXXII Block A, P-4 and 5, Kolkata, West Bengal 700029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mahuya Bhattacharyya |
Manipal Hospital(Former AMRI Hospitals) |
Dept Of Critical Care
Division Dhakuria
C.I.T Scheme, Gariahat Rd, LXXII Block A, P-4 and 5, Kolkata, Pin code 700029
Kolkata
WEST BENGAL |
9831024409
mohua20002000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| EC AMRI HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B96||Other bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult ICU admitted patients with community acquired sepsis during pre (2018, 2019) and post (2022,2023) COVID 19 era |
|
| ExclusionCriteria |
| Details |
Patients with incomplete data, treatment withdrawn, discharged against medical advice, diagnosis uncertain |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison between pre and post COVID 19 groups on following points
1. hospital mortality
2. ICU length of stay
|
1. Mortality will be assessed on discharge from hospital.
2. Length of stay will be assessed at discharge from ICU.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of illness |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
02/06/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to compare clinical profile and hospital outcome in patients admitted in pre and post COVID 19 era. This is an observational study where data will be retrieved from the electronic database of the department. The place of the study is mixed medical-surgical ICUs of a tertiary care hospital. All adult patients with a diagnosis of community acquired sepsis will be analysed. Proposed number of participants is 1000 or more in each group. Primary outcome parameters will include hospital mortality, ICU length of stay. |