| CTRI Number |
CTRI/2019/05/019125 [Registered on: 14/05/2019] Trial Registered Prospectively |
| Last Modified On: |
03/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Point Prevalence |
| Study Design |
Other |
|
Public Title of Study
|
Sepsis in India Prevalence Study |
|
Scientific Title of Study
|
Prevalence of sepsis in critically ill patients in India: A single-day, prospective, observational, multicentre, nation-wide point-prevalence study |
| Trial Acronym |
SIPS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACTRN12619000012178p |
ANZCTR |
| U111112166758 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bala Venkatesh |
| Designation |
Professor |
| Affiliation |
The George Institute for Global Health |
| Address |
11-312, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre
New Delhi 110025 India
New Delhi
DELHI
110025
India |
| Phone |
434980385 |
| Fax |
|
| Email |
bvenkatesh@georgeinstitute.org.au |
|
Details of Contact Person
Scientific Query
|
| Name |
Bala Venkatesh |
| Designation |
Professor |
| Affiliation |
The George Institute for Global Health |
| Address |
11-312, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre
New Delhi 110025 India
New Delhi
DELHI
110025
India |
| Phone |
434980385 |
| Fax |
|
| Email |
bvenkatesh@georgeinstitute.org.au |
|
Details of Contact Person
Public Query
|
| Name |
Bala Venkatesh |
| Designation |
Professor |
| Affiliation |
The George Institute for Global Health |
| Address |
11-312, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre
New Delhi 110025 India
New Delhi
DELHI
110025
India |
| Phone |
434980385 |
| Fax |
|
| Email |
bvenkatesh@georgeinstitute.org.au |
|
|
Source of Monetary or Material Support
|
| The George Institute for Global Health |
|
|
Primary Sponsor
|
| Name |
The George Institute for Global Health |
| Address |
Level 5, 1 King St Newtown, NSW, 2042
Australia
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parmeet Arora |
Apollo Hospitals, Hyderabad |
Plot No. 3-5-874/1, Near, Old MLA Quarters Rd, Old MLA Quarters, Hyderguda, Hyderabad, Telangana 500029, India
Rangareddi
ANDHRA PRADESH |
8427016170
dr.parmeet_k@apolloimsr.edu.in |
| Dr Bharath Kumar |
Apollo main hospital Chennai |
No: 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu 600006, India
Chennai
TAMIL NADU |
9591100655
bharath@icuconsultants.com |
| Dr Kishore Mangal |
Eternal Hospital, Jaipur |
No. 3A Jagatpura Road, Near, Jawahar Circle, Sector 8, Jaipur, Rajasthan 302017, India
Jaipur
RAJASTHAN |
18001213422
drkishoremangal@gmail.com |
| Rahul Pandit |
Fortis hospital in Mumbai |
Raheja Rugnalaya Marg, Mahim (W), Mumbai, Maharashtra – 400016, India
Mumbai (Suburban)
MAHARASHTRA |
9820595519
rahul.pandit@fortishealthcare.com |
| Dr Niyaz Ashraf |
IQRAA hospital Calicut |
Wayanad Rd, Malaparamba, Kozhikode, Kerala 673009, India
Kozhikode
KERALA |
4952379100
niyazashraf@gmail.com |
| Dr Khalid Ansari |
Kaleskar Hospital, Mumbai |
Opposite Kalsekar Degree College, Dawla Village, Kausa, Mumbra, Thane, Maharashtra 400612, India
Mumbai (Suburban)
MAHARASHTRA |
9975211798
drkhalidahmadansari1974@gmail.com |
| Dr Mahesh Balakrishna |
Malabar Institute of Medical Sciences |
Mini Bypass Rd, Govindapuram, Kozhikode, Kerala 673016, India
Kozhikode
KERALA |
9207226555
mahesh.bs@asterhospital.com |
| Dr Narayana |
PGI Chandigarh |
Sector 12, Chandigarh, 160012, India
Chandigarh
CHANDIGARH |
1722747585
narayana.yaddanapudi@gmail.com |
| Dr Prachee Sathe |
Ruby Hall clinic hospital, Pune |
40, Sasoon Rd, Sangamvadi, Pune, Maharashtra 411001, India
Pune
MAHARASHTRA |
9960686867
prachee.sathe@gmail.com |
| Prof Bhuvana Krishna |
St John Medical College Hospital, Bangalore |
Sarjapur Main Rd, Beside Bank Of Baroda, John Nagar, Koramangala, Bengaluru, Karnataka 560034, India
Bangalore
KARNATAKA |
9945693221
bhuvana.11@gmail.com |
| Dr Prathiba Dileep |
Zydus hospital, Ahemdabad |
100 Feet Road, Sarkhej Bridge, Nr, Sarkhej - Gandhinagar Hwy, Ahmedabad, Gujarat 380054, India
Ahmadabad
GUJARAT |
9825023998
pratibhadileep@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| AIMSR Research Committee |
No Objection Certificate |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| PGIMER |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A418||Other specified sepsis, |
|
|
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 |
All adult patients (18 years or older) present in the ICU at the start of the study day or admitted during the 24-hour study period will be included in the study sample. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this project is to examine sepsis epidemiology and characterize the antibiotic use and antimicrobial resistance in Indian ICUs. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe sepsis patient clinical characteristics, antimicrobial use, treatments received, and 30 day outcomes
|
Day 30 |
| To undertake a gender specific analysis to determine if prevalence, characteristics and outcomes of male and female patients with sepsis differ |
NA |
| To describe the antibiotic usage and antimicrobial resistance in Indian ICUs |
NA |
| To describe hospital level antibiotic stewardship practices |
NA |
| To describe ICU level processes of care |
NA |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "666"
Final Enrollment numbers achieved (India)="666" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A single-day, prospective, observational, multicentre, nation-wide point-prevalence study of sepsis in Indian Intensive Care Units.
Data will be collected over a designated 24-hour study day, starting 08:00 am on the study day till 08:00 am on the following day.
For ICUs participating in this study, a questionnaire to collect hospital- and ICU-level data will be administered along with individual patient data.Data analysis will be guided by a statistical analysis plan, which will be developed before the database is locked. Data analysis will be undertaken at the George Institute for Global Health by statisticians using a statistical software package. To address the primary objectives descriptive statistics will be used including univariate comparisons. |