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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
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Trial registered on ANZCTR
Registration number
ACTRN12625000650493p
Ethics application status
Submitted, not yet approved
Date submitted
2/06/2025
Date registered
19/06/2025
Date last updated
19/06/2025
Date data sharing statement initially provided
19/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Are blood cultures taken from an arterial line as good as blood cultures taken from a peripheral venous sample to diagnose sepsis in patients in the intensive care unit?
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Scientific title
Evaluating whether blood cultures taken from an arterial line produce non-inferior contamination rates compared to peripheral blood cultures in ICU patients with suspected bloodstream infection
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Secondary ID [1]
314573
0
Nil known
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Universal Trial Number (UTN)
U1111-1323-6862
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Trial acronym
EASI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
337675
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Condition category
Condition code
Infection
334010
334010
0
0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
- When an ICU patient with an arterial line in situ in a study site has blood cultures taken due to suspected bloodstream infection, they will be enrolled in the study
- Two sets of blood cultures will be requested: One set from the arterial line and one from a peripheral venepunture
- Both blood cultures will be taken with aseptic technique
- The timing for taking these blood cultures will be not be mandated for this study, however there will be a recommendation to take blood cultures as a possible following the request, as per usual protocol.
- The blood cultures will only be used in the final analysis if the arterial line cultures and peripheral line cultures are taken within 6 hours of each other.
- The blood culture samples will be sent to the laboratory as part of the usual processes within the hospital.
- The name of any microorganism grown in the blood culture, along with date and time of growth will be recorded.
- The study will continue until a pre-specified number to culture sets are obtained (484).
- Positive blood culture results will be assessed by infectious disease specialists in each study site to determine if results are true positives or false positives (contaminants).
- Other data from medical records not immediately relevant for assessing blood cultures will not be obtained.
- No follow up data or questionnaires will be performed following the initial blood culture collection, however patients may have further sets of blood cultures taken as part of this study if they meet the relevant criteria.
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Intervention code [1]
331195
0
Diagnosis / Prognosis
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Comparator / control treatment
Rates of contamination in arterial line blood cultures will be compared to rates of contamination in peripheral venepuncture blood cultures. The 'reference' comparator will be the continuation rate in peripheral venipuncture blood cultures.
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Control group
Active
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Outcomes
Primary outcome [1]
341671
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The rate of false positive blood culture results from arterial line samples compared to the rate of false positive blood culture results from peripheral venesection samples.
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Assessment method [1]
341671
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The false positive rate will be defined as the number of contaminants divided by the sum of the number of contaminants plus the number of true negatives.
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Timepoint [1]
341671
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Blood cultures will be incubated for five days post sample-collection
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Secondary outcome [1]
448329
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The sensitivity for detecting true bloodstream infection (true positives) in arterial line blood culture samples compared to peripheral blood culture samples.
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Assessment method [1]
448329
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Sensitivity will be calculated as true positives divided by true positives plus false negatives
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Timepoint [1]
448329
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Blood cultures will be incubated for five days post sample-collection
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Secondary outcome [2]
448331
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The specificity for detecting true negative negatives in both arterial line blood culture samples and peripheral blood culture samples
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Assessment method [2]
448331
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Specificity will be calculated as true negatives divided by true negatives plus false positives
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Timepoint [2]
448331
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Blood cultures will be incubated for five days post sample-collection
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Secondary outcome [3]
448339
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Positive predictive value for a positive result in both arterial line blood cultures and peripheral blood cultures
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Assessment method [3]
448339
0
Positive predictive value will be calculated as the number of true positive blood culture results divided by the number of true positives plus the number of false positives
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Timepoint [3]
448339
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Blood cultures will be incubated for five days post sample-collection
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Secondary outcome [4]
448340
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Negative predictive value for a negative result in both arterial line blood cultures and peripheral blood cultures
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Assessment method [4]
448340
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Negative predictive value will be calculated as the number of true negative blood culture results divided by the number of true negatives plus the number of false negatives.
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Timepoint [4]
448340
0
Blood cultures will be incubated for five days post sample-collection
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Secondary outcome [5]
448344
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Time to positivity of positive arterial line culture results compared to the time to positivity of positive peripheral blood culture results
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Assessment method [5]
448344
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The mean total time in minutes (as per timing of the laboratory records) from the time of sampling to the time of positive growth detected will be recorded for positive arterial line blood cultures and peripheral blood cultures.
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Timepoint [5]
448344
0
The mean total time in minutes (as per timing of the laboratory records) from the time of sampling to the time of positive growth detected will be recorded for positive arterial line blood cultures and peripheral blood cultures.
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Eligibility
Key inclusion criteria
- Adult patients in ICU with an arterial line in situ who have blood cultures taken for suspected bloodstream infection
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Patients under 16
- Patients with a known allergy to chlorhexidine
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Study design
Purpose
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Our primary analysis will be a noninferiority comparison of the contamination proportion between arterial line samples compared to the rate of false positive blood culture results from peripheral venesection samples. This comparison is based on the advantage that drawing blood from an indwelling arterial catheter enables prompt initiation of antimicrobial therapy and does not require venepuncture, which is often demanding in critically ill patients. Our noninferiority margin will be set a priori at þ2.0% in contamination difference (arterial catheters– venepuncture). The size of the margin was determined on the basis of the baseline contamination proportion of the participating hospitals of approximately 4%. We will declare noninferiority of blood culture from arterial catheters if the upper limit of the one-sided 95% CI of the contamination difference does not exceed the predefined margin of 2%. We will construct the 95% CI and calculate the P value for noninferiority using Nam’s score method, accounting for the paired nature of the observations. The calculated sample size is 484 paired blood cultures with a 5% one-sided significance level and 80% power, assuming that the contamination proportions for samples drawn from arterial catheters and by venipuncture were both 4%. We plan to include 484 paired blood cultures in this study. Data will be prospectively collected using a standardized case report form. Patient characteristics and procedures will be presented as medians with interquartile ranges (IQRs) for continuous variables and proportions for categorical variables. Sensitivity, specificity, PPV, and NPV will be calculated with Clopper-Pearson exact 95% CI. All statistical analyses will be performed with R (version 4.2.0; R Foundation for Statistical Computing).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
7/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
484
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27098
0
New Zealand
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State/province [1]
27098
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Auckland
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Funding & Sponsors
Funding source category [1]
319123
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Commercial sector/Industry
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Name [1]
319123
0
Edwards Lifesciences
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Address [1]
319123
0
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Country [1]
319123
0
United States of America
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Primary sponsor type
Hospital
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Name
Department of Critical Care Medicince (Auckland City Hospital)
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Address
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Country
New Zealand
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Secondary sponsor category [1]
321596
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None
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Name [1]
321596
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None
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Address [1]
321596
0
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Country [1]
321596
0
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
317715
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
317715
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https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
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Ethics committee country [1]
317715
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New Zealand
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Date submitted for ethics approval [1]
317715
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02/06/2025
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Approval date [1]
317715
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Ethics approval number [1]
317715
0
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Summary
Brief summary
Blood cultures remain the gold-standard investigation for the diagnosis of bloodstream infection in patients admitted to intensive care units. National and international guidelines state that blood cultures should be taken by peripheral venesection to avoid contamination. Peripheral venesection in ICU patients is frequently challenging and time-consuming and can represent a burden for the patient (pain, discomfort) and the clinician (an extra lengthy procedure in a busy shift). A recent study conducted in Japan in 2023 found that blood culture contamination rates from arterial samples were non-inferior to contamination rates from peripheral venesection samples, suggesting that taking arterial line samples for blood cultures is a viable strategy. The purpose of this study is to determine whether taking blood samples for bacterial culture from arterial catheters that are already in place in ICU patients has an acceptably low rate of contamination compared to newly taken blood samples from venepuncture (using a needle to take a sample from a vein). A secondary aim is to determine whether arterial blood cultures may also have increased sensitivity for true bacterial infection compared to venepuncture.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
141914
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Dr Timothy Wareing
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Address
141914
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Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
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Country
141914
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New Zealand
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Phone
141914
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+64 274064396
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Fax
141914
0
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Email
141914
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[email protected]
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Contact person for public queries
Name
141915
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Timothy Wareing
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Address
141915
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Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
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Country
141915
0
New Zealand
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Phone
141915
0
+64 274064396
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Fax
141915
0
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Email
141915
0
[email protected]
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Contact person for scientific queries
Name
141916
0
Timothy Wareing
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Address
141916
0
Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
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Country
141916
0
New Zealand
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Phone
141916
0
+64 274064396
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Fax
141916
0
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Email
141916
0
[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
No requirements
What individual participant data might be shared?
•
De-identified individual participant data:
•
Published results
What types of analyses could be done with individual participant data?
•
Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Principal investigator: Dr Chris Hands,
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Other
Data Management Plan
Data_Management__Plan_V1_02.06.25.docx
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.
Download to PDF