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Trial registered on ANZCTR


Registration number
ACTRN12616001152415p
Ethics application status
Not yet submitted
Date submitted
14/08/2016
Date registered
24/08/2016
Date last updated
24/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients.
Scientific title
A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients
Secondary ID [1] 289691 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 299491 0
coagulation 299492 0
Condition category
Condition code
Infection 299475 299475 0 0
Other infectious diseases
Blood 299476 299476 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients admitted to intensive care who fulfil Systemic Inflammatory Response Syndrome (SIRS) criteria and are clinically thought to have sepsis will have a sample of blood taken to perform a thromboelastogram (TEG) both at admission and on discharge. These results will be correlated with blood culture results from samples that have been taken at clinically appropriate times - no additional blood culture samples will be taken. The patient will not be clinically followed up after discharge for the purposes of this study.
Intervention code [1] 295312 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298954 0
To determine whether the TEG results from patients who are admitted to the ICU with clinically diagnosed sepsis (using SIRS criteria and clinical suspicion of an infectious source) are correlated to obtaining a positive blood culture result.
Timepoint [1] 298954 0
The blood samples will be taken on admission to ICU.
Secondary outcome [1] 325761 0
To determine if standard laboratory coagulation studies correlate with the TEG changes in culture positive sepsis
Timepoint [1] 325761 0
Results from the routine blood tests taken on admission to ICU will be compared to blood samples taken for TEG at admission
Secondary outcome [2] 326931 0
To determine if TEG changes on discharge from the ICU have resolved with clinical improvement
Timepoint [2] 326931 0
Blood sample will be taken on discharge from ICU
Secondary outcome [3] 326932 0
Diagnosis on admission to hospital, by review of hospital records
Timepoint [3] 326932 0
At time of admissin
Secondary outcome [4] 326933 0
Diagnosis on admission to ICU, by review of hospital records
Timepoint [4] 326933 0
At time of admission
Secondary outcome [5] 326934 0
Length of stay in the ICU, by review of hospital records
Timepoint [5] 326934 0
At time of ICU discharge
Secondary outcome [6] 326935 0
Source of sepsis, by review of hospital records
Timepoint [6] 326935 0
At time of ICU discharge
Secondary outcome [7] 326936 0
Use of vasoactive drugs, by review of hospital records
Timepoint [7] 326936 0
At time of ICU discharge
Secondary outcome [8] 326937 0
Hospital mortality, by review of hospital records
Timepoint [8] 326937 0
At time of hospital discharge or death

Eligibility
Key inclusion criteria
Patients admitted to ICU who;
- are aged >18 years
- Have SIRS; 2 of the following criteria on admission;
- Temperature >38 or <36
- Pulse rate >90/minute
- Respiratory rate >20/minute or PaCo2 <32mmHg
- White cell count >12 or >10% immature bands
- Clinical diagnosis of sepsis
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-existing diagnosis of a coagulation disorder
- On anticoagulant treatment eg heparin infusion, treatment dose low-molecular weight heparin, warfarin or oral anticoagulants

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

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 in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6181 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 13614 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 294144 0
Hospital
Name [1] 294144 0
Logan Hospital Intensive Care Unit
Address [1] 294144 0
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook
QLD
4131
Country [1] 294144 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, Logan Hospital
Address
Cnr Armstrong and Loganlea Rds
Meadowbrook
QLD
4131
Country
Australia
Secondary sponsor category [1] 292974 0
None
Name [1] 292974 0
Address [1] 292974 0
Country [1] 292974 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 295555 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 295555 0
Princess Alexandra hospital
199 Ipswich Road
Woolloongabba 4102
Ethics committee country [1] 295555 0
Australia
Date submitted for ethics approval [1] 295555 0
30/08/2016
Approval date [1] 295555 0
Ethics approval number [1] 295555 0

Summary
Brief summary
This study will examine if there are changes in coagulation which can be detected by TEG that occur in patients with a bacteraemia before it has been detected in blood cultures.
The benefits of being aware of these potential changes may include earlier consideration of non-infective causes of SIRS and altered antibiotic prescribing practices. In contrast, early identification of a potentially life-threatening infective process that is responsible for the SIRS presentation is essential to ensure ‘ideal outcomes’ for patients (1). It is a common and important clinical challenge to distinguish between those patients who have sepsis and those who have SIRS. A hypocoagulable state in sepsis is thought to be associated with increased mortality. Specifically, impaired fibrinolysis may be associated with a diagnosis of sepsis versus SIRS (2).
On admission to ICU, patients generally have a set of routine admission bloods sampled; these may include full blood count, electrolytes, renal and hepatic function and a coagulation profile. Routine blood tests may also include blood cultures if the patient is thought to be septic. However, the routine coagulation profile sent to pathology is thought to provide limited clinical information when assessing in vivo hypocoaguable changes (2). Research has demonstrated that TEG parameter changes throughout an episode of sepsis may provide some predictive value for mortality and risk of bleeding (3). Recent research has aimed to identify early TEG parameters that may predict a positive blood culture result (4).
The aim of our study is to identify blood changes detected by TEG that may indicate whether a patient has sepsis or a non-infective cause for SIRS.
References;
1. Simpson S. New Sepsis Criteria; A change we should not make. Chest. 2016; 149(5).
2. Muller MC, Meijers JCM, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Critical care (London, England). 2014; 18(1):R30-R.
3. Haase N, Ostrowski SR, Wetterslev J, Lange T, Moller MH, Tousi H, et al. Thromboelastography in patients with severe sepsis: a prospective cohort study. Intensive Care Medicine. 2015; 41(1):77-85.
4. Grant HW, Hadley GP. Prediction of neonatal sepsis by thromboelastography. Pediatric Surgery International. 1997; 12(4):289-92.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67454 0
Dr Hayden White
Address 67454 0
Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD

Country 67454 0
Australia
Phone 67454 0
+61 7 3299 8755
Fax 67454 0
+61 7 3299 8376
Email 67454 0
Hayden.White@health.qld.gov.au
Contact person for public queries
Name 67455 0
Dr Hayden White
Address 67455 0
Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD
Country 67455 0
Australia
Phone 67455 0
+61 7 3299 8755
Fax 67455 0
+61 7 3299 8376
Email 67455 0
Hayden.White@health.qld.gov.au
Contact person for scientific queries
Name 67456 0
Dr Hayden White
Address 67456 0
Director of Intensive Care
Logan Hospital
Cnr Armstrong and Loganlea Roads
Meadowbrook 4131
QLD
Country 67456 0
Australia
Phone 67456 0
+61 7 3299 8755
Fax 67456 0
+ 61 7 3299 8376
Email 67456 0
Hayden.White@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results