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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?
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
Secondary ID [1] 314573 0
Nil known
Universal Trial Number (UTN)
U1111-1323-6862
Trial acronym
EASI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 337675 0
Condition category
Condition code
Infection 334010 334010 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
- 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.
Intervention code [1] 331195 0
Diagnosis / Prognosis
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.
Control group
Active

Outcomes
Primary outcome [1] 341671 0
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.
Timepoint [1] 341671 0
Blood cultures will be incubated for five days post sample-collection
Secondary outcome [1] 448329 0
The sensitivity for detecting true bloodstream infection (true positives) in arterial line blood culture samples compared to peripheral blood culture samples.
Timepoint [1] 448329 0
Blood cultures will be incubated for five days post sample-collection
Secondary outcome [2] 448331 0
The specificity for detecting true negative negatives in both arterial line blood culture samples and peripheral blood culture samples
Timepoint [2] 448331 0
Blood cultures will be incubated for five days post sample-collection
Secondary outcome [3] 448339 0
Positive predictive value for a positive result in both arterial line blood cultures and peripheral blood cultures
Timepoint [3] 448339 0
Blood cultures will be incubated for five days post sample-collection
Secondary outcome [4] 448340 0
Negative predictive value for a negative result in both arterial line blood cultures and peripheral blood cultures
Timepoint [4] 448340 0
Blood cultures will be incubated for five days post sample-collection
Secondary outcome [5] 448344 0
Time to positivity of positive arterial line culture results compared to the time to positivity of positive peripheral blood culture results
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.

Eligibility
Key inclusion criteria
- Adult patients in ICU with an arterial line in situ who have blood cultures taken for suspected bloodstream infection
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients under 16
- Patients with a known allergy to chlorhexidine

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
484
Accrual to date
Final
Recruitment outside Australia
Country [1] 27098 0
New Zealand
State/province [1] 27098 0
Auckland

Funding & Sponsors
Funding source category [1] 319123 0
Commercial sector/Industry
Name [1] 319123 0
Edwards Lifesciences
Country [1] 319123 0
United States of America
Primary sponsor type
Hospital
Name
Department of Critical Care Medicince (Auckland City Hospital)
Address
Country
New Zealand
Secondary sponsor category [1] 321596 0
None
Name [1] 321596 0
None
Address [1] 321596 0
Country [1] 321596 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317715 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317715 0
Ethics committee country [1] 317715 0
New Zealand
Date submitted for ethics approval [1] 317715 0
02/06/2025
Approval date [1] 317715 0
Ethics approval number [1] 317715 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141914 0
Dr Timothy Wareing
Address 141914 0
Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
Country 141914 0
New Zealand
Phone 141914 0
+64 274064396
Fax 141914 0
Email 141914 0
[email protected]
Contact person for public queries
Name 141915 0
Timothy Wareing
Address 141915 0
Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
Country 141915 0
New Zealand
Phone 141915 0
+64 274064396
Fax 141915 0
Email 141915 0
[email protected]
Contact person for scientific queries
Name 141916 0
Timothy Wareing
Address 141916 0
Department of Critical Care Medicine, 2 Park Road, Grafton, Auckland 1023
Country 141916 0
New Zealand
Phone 141916 0
+64 274064396
Fax 141916 0
Email 141916 0
[email protected]

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?

TypeCitationLinkEmailOther DetailsAttachment
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.