Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000637943
Ethics application status
Approved
Date submitted
21/04/2011
Date registered
23/06/2011
Date last updated
23/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determine if elevated level of bacteria in the blood is associated with increased risk of death
Scientific title
Bacteraemic Load in Septic Shock - Substudy of ARISE to quantify bacterial and immune response markers in the bloodstream of patients with septic shock.
Secondary ID [1] 260054 0
ARISE study Registration ID :ACTRN12608000053325
Universal Trial Number (UTN)
Trial acronym
BLISS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Septic Shock 267946 0
Condition category
Condition code
Infection 265858 265858 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 268261 268261 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Any patient enrolled in the "Australasian Resuscitation in Sepsis Evaluation (ARISE)" study and has or is going to have an arterial line inserted as part of their care, for monitoring blood pressure and to assist with blood taking, will be eligible for this study. Patient will be enrolled into BLISS study within 2 hours of enrollment into ARISE study.

Bliss study will require only few sets of blood.
In the great majority of cases, these additional blood samples will be drawn at the same time as that drawn for routine tests, which is normally very frequent in the early stages of serious illness. We will perform test to see the levels of bacteria in the blood in various time point, e.g. at enrolment, 3 hrs, 6 hrs, 12 hrs, day 1, day 2 and day 3.

Blood collection will continure up to first 72 hours of hospital admission. Clincial assessment will be performed for 10 days if they are in hospital.
Intervention code [1] 264613 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 266621 0
All cause mortality assessed
Timepoint [1] 266621 0
90 days after enrolment in the ARISE study
Primary outcome [2] 268990 0
Bacterial load on presentation to hospital and changes in bacteraemic load over time will be assessed by blood analysis using multiplexed PCR technology.
Timepoint [2] 268990 0
For that admission
Secondary outcome [1] 276102 0
1. Organ failure as determined by the Sequential Organ Failure Assessment (SOFA) method
Timepoint [1] 276102 0
For that admission
Secondary outcome [2] 276406 0
ICU Survival
Timepoint [2] 276406 0
For that admission
Secondary outcome [3] 276407 0
Hospital Survival
Timepoint [3] 276407 0
For that admission

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion in BLISS if they meet all of the following criteria:
1. Patient has been enrolled in the ARISE Study and less than 2 hours has elapsed since the time of randomisation into ARISE.
2. Patient has or will receive an arterial line
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Same as ARISE exclusion criteria:
age < 18 years, pregnancy, central venous catheterisation or blood transfusion contraindicated, haemodynamic instability due to active bleeding, underlying disease process with a life-expectancy < 90 days, inevitable imminent death, any limitation-of-therapy order, or refused consent.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264948 0
Government body
Name [1] 264948 0
National Health and Medical Research Council
Country [1] 264948 0
Australia
Primary sponsor type
Hospital
Name
Infectious Disease and Microbiology, Westmead Hosptial
Address
Cnr Hawkesbury Rd & Darcy St Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 264045 0
University
Name [1] 264045 0
Monash University
Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) at School of Public Health and Preventive Medicine (SPHPM)
Address [1] 264045 0
Department of Epidemiology & Preventive Medicine, School of Public
Health and Preventive Medicine Monash University, The Alfred Centre,
Commercial Road, Melbourne, Vic 3004

Delivery Address:
L6 The Alfred Centre, B Lobby (via Centre Lane),
99 Commercial Road, Melbourne, VIC 3004
Country [1] 264045 0
Australia
Secondary sponsor category [2] 264046 0
Other Collaborative groups
Name [2] 264046 0
Centre for Clinical Research in Emergency Medicine, Western Australian Institute for Medical Research
Address [2] 264046 0
Centre for Clinical Research in Emergency Medicine
Western Australian Institute for Medical Research Levels 5/6,
MRF Building Rear 50 Murray Street Perth, WA 6000
Country [2] 264046 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266908 0
Western Sydney Local Health Network- Human Research Ethics Committee (Westmead Campus)
Ethics committee address [1] 266908 0
Westmead Hospital
Hawkesbury Road,
Westmead, NSW 2145
Ethics committee country [1] 266908 0
Australia
Date submitted for ethics approval [1] 266908 0
11/02/2010
Approval date [1] 266908 0
10/03/2010
Ethics approval number [1] 266908 0
HREC2010/2/4.11(3118) AU REd HREC/10/WMEAD/43

Summary
Brief summary
When a person has severe sepsis or septic shock, a severe infection, their body reacts to the infection by a process known as inflammation. This inflammation impairs the working of and can damage important organs in the body such as the heart, kidney and lungs.

The purpose of the study is to find out the best way to detect and monitor infection and inflammation in the body. We know from previous studies that severe sepsis and septic shock is usually caused by bacteria. We would like to investigate the concentration of bacteria in the blood of persons with severe sepsis when they first present to hospital and also to monitor changes in the concentration of bacteria in the blood over time to determine what the effects of these factors are on organ failure and survival of patients.
Trial website
Nil
Trial related presentations / publications
We haven't published any paper for this study yet.
Public notes

Contacts
Principal investigator
Name 32529 0
Address 32529 0
Country 32529 0
Phone 32529 0
Fax 32529 0
Email 32529 0
Contact person for public queries
Name 15776 0
Prof Jon Iredell
Address 15776 0
Centre of Infectious Disease and Microbiology
Level 3, ICPMR Building
Cnr of Darcy and Hawkesbury Rd, Westmead
NSW 2145
Country 15776 0
Australia
Phone 15776 0
+61 2 9845 6255
Fax 15776 0
+61 2 9845 5317
Email 15776 0
[email protected]
Contact person for scientific queries
Name 6704 0
Prof Jon Iredell
Address 6704 0
Centre of Infectious Disease and Microbiology
Level 3, ICPMR Building
Cnr of Darcey and Hawkesbury Rd, Westmead
NSW 2145
Country 6704 0
Australia
Phone 6704 0
+61 2 9845 6255
Fax 6704 0
+61 2 9891 5317
Email 6704 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.