The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000012178p
Ethics application status
Submitted, not yet approved
Date submitted
20/12/2018
Date registered
8/01/2019
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Sepsis in India Prevalence Study (SIP Study)
Scientific title
Sepsis in India Prevalence Study: A single-day, prospective, observational, multicentre, nation-wide point-prevalence study
Secondary ID [1] 295427 0
nil known
Universal Trial Number (UTN)
U1111-1216-6758
Trial acronym
SIP
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Sepsis 308981 0
Condition category
Condition code
Inflammatory and Immune System 307876 307876 0 0
Other inflammatory or immune system disorders
Infection 307877 307877 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 301957 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306849 0
To estimate the prevalence of sepsis in Indian ICUs.
It will be assessed via a case report form (CRF) data collection tool over a 24 hour study period.
Timepoint [1] 306849 0
Study day- 24 hour period (8:00am-8:00am)
Secondary outcome [1] 349934 0
Using a Case Report Form (CRF) 30 day outcomes will be assessed for each patient. The outcome is to be able to describe the prevalence of these characteristics in a population of sepsis patients.
Timepoint [1] 349934 0
Day 30 (post study day period), counting the study day as Day 1.
Secondary outcome [2] 365407 0
Using a Case Report Form (CRF) sepsis patient characteristics will be assessed. The outcome is to be able to describe the prevalence of these characteristics in a population of sepsis patients
Timepoint [2] 365407 0
Study day- 24 hour period (8:00am-8:00am)
Secondary outcome [3] 365408 0
Using a Case Report Form (CRF), patient antimicrobial use will be assessed.
The outcome is to be able to describe the prevalence of this characteristic in a population of sepsis patients.
Timepoint [3] 365408 0
Study day- 24 hour period (8:00am-8:00am)
Secondary outcome [4] 365409 0
Using a Case Report Form (CRF) the treatments that pateints received will be assessed. The outcome is to be able to describe the prevalence of these treatments in a population of sepsis patients.
Timepoint [4] 365409 0
Study day- 24 hour period (8:00am-8:00am)
Secondary outcome [5] 365410 0
Using a Case Report Form (CRF) patient limitations of care will be assessed. The outcome is to be able to describe the prevalence of this characteristic in a population of sepsis patients.
Timepoint [5] 365410 0
Study day- 24 hour period (8:00am-8:00am)

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NONE

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10678 0
India
State/province [1] 10678 0

Funding & Sponsors
Funding source category [1] 301502 0
Other
Name [1] 301502 0
The George Institute for Global Health
Address [1] 301502 0
Level 5, 1 King St, Newtown, NSW, 2042
Country [1] 301502 0
Australia
Primary sponsor type
Other
Name
The George Institute for Global Health
Address
Level 5, 1 King St, Newtown, NSW, 2042
Country
Australia
Secondary sponsor category [1] 301199 0
None
Name [1] 301199 0
NA
Address [1] 301199 0
NA
Country [1] 301199 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300867 0
Indian Council of Medical Research, ICMR
Ethics committee address [1] 300867 0
V. Ra malingaswami Bhawan, Ansari Nagar,
New Delhi - 110029
Ethics committee country [1] 300867 0
India
Date submitted for ethics approval [1] 300867 0
20/12/2018
Approval date [1] 300867 0
Ethics approval number [1] 300867 0

Summary
Brief summary
Point prevalence study in India to identify sepsis prevalence in Indian ICUs
In 2017, The World Health Organization recognised sepsis as a global health priority. The true disease burden of sepsis remains unknown as the current estimates of disease burden are largely based on the data from high income countries (HIC). Even though the majority of the global population lives in lower/middle income countries (LMICs), there is a scarcity of sepsis epidemiology data from LMICs. In countries such as India, 1 in 3 people who develop sepsis die. Many of these deaths are preventable but the epidemiology of sepsis is poorly understood. This problem is further compounded by a very high level of antimicrobial resistance. This study will provide up-to-date knowledge of the epidemiology and outcomes of sepsis, antibiotic use and antimicrobial resistance in intensive care units (ICUs) in Indian hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85090 0
Dr Naomi Hammond
Address 85090 0
The George Institute for Global Health.
Level 5, 1 King St Newtown, NSW, 2042
Country 85090 0
Australia
Phone 85090 0
61+ 2 8052 4300
Fax 85090 0
Email 85090 0
nhammond@georgeinstitute.org.au
Contact person for public queries
Name 85091 0
Dr Naomi Hammond
Address 85091 0
The George Institute for Global Health.
Level 5, 1 King St Newtown, NSW, 2042
Country 85091 0
Australia
Phone 85091 0
61+ 2 8052 4300
Fax 85091 0
Email 85091 0
nhammond@georgeinstitute.org.au
Contact person for scientific queries
Name 85092 0
Dr Naomi Hammond
Address 85092 0
The George Institute for Global Health.
Level 5, 1 King St Newtown, NSW, 2042
Country 85092 0
Australia
Phone 85092 0
61+ 2 8052 4300
Fax 85092 0
Email 85092 0
nhammond@georgeinstitute.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Undecided at this point of time due to considerations under Indian Law.
What supporting documents are/will be available?
No other documents available
Summary results
No Results