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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035392
Receipt No. R000040169
Scientific Title Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Date of disclosure of the study information 2018/12/29
Last modified on 2019/07/02

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Basic information
Public title Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Acronym Contamination of blood cultures from arterial catheters (CONTACT study)
Scientific Title Contamination of blood cultures from arterial catheters vs peripheral venipuncture in critically ill patients: A multicenter prospective observational study
Scientific Title:Acronym Contamination of blood cultures from arterial catheters (CONTACT study)
Region
Japan

Condition
Condition Suspected bacteremia in adult critically ill patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the contamination of blood cultures drawn from arterial catheters is non-inferior to that of blood cultures drawn from peripheral venipuncture in adult critically ill patients.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The proportions of blood culture contamination

Assessment of the primary outcome: every positive blood culture will be evaluated with two staff infectious disease specialists who will be blinded to the source of the blood culture (arterial catheters or skin puncture).
Key secondary outcomes The volumes of collected blood; the sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value and negative predictive value of true bacteremia

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Blood cultures collected during clinically suspected episodes of bacteremia AND
1. Obtained from adult (20 years or older) critically ill patients
2. A paired blood culture sets, consisting of one blood culture set drawn from existing arterial catheters and one blood culture set drawn from peripheral skin punctures.

All blood cultures obtained from adult critically ill patients will be screened for eligibility during the study period. All consecutive blood culture sets will be enrolled if they fulfill the inclusion criteria and none of the exclusion criteria.
Key exclusion criteria 1. Obtained from arterial lines without a closed blood sampling system
2. Percutaneous procedures (PCI, IVR) had performed through the arterial line
3. Inappropriately labeled blood cultures
4. Enrolled in this study previously
5. Refusal of study participation
Target sample size 590

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Nakayama
Organization Okinawa Chubu Hospital
Division name Intensive Care Unit
Zip code 904-2293
Address 281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL 098-973-4111
Email izunakayama-circ@umin.org

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Nakayama
Organization Okinawa Chubu Hospital
Division name Intensive Care Unit
Zip code 904-2293
Address 281 Miyazato, Uruma, Okinawa 904-2293, Japan
TEL 098-973-4111
Homepage URL
Email izunakayama-circ@umin.org

Sponsor
Institute Okinawa Chubu Hospital, Intensive Care Unit
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sakai City Medical Center
Kameda General Hospital
Musashino Red Cross Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okinawa Chubu Hospital Research ethics committees
Address 281 Miyazato, Uruma, Okinawa, Japan
Tel 0989734111
Email izunakayama-circ@umin.org

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 沖縄県立中部病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 29 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 12 Month 02 Day
Date of IRB
2018 Year 12 Month 27 Day
Anticipated trial start date
2018 Year 12 Month 29 Day
Last follow-up date
2021 Year 12 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Sample size calculation: This study is designed to investigate whether the contamination proportions of blood cultures drawn from arterial catheters are noninferior to those of blood cultures drawn from skin punctures. The calculated sample size is 590 paired blood culture sets based on a noninferiority margin of 2% for an absolute increase in the contamination proportions of arterial catheter blood cultures versus skin puncture blood cultures, a 1-sided alpha of 5%, and 80% power, assuming a baseline contamination proportion of 1.6%. A noninferiority margin of 2% was set based on the recommendation from Clinical and Laboratory Standards institute (recommended proportion of contamination <3%). A baseline contamination proportion of 1.6% was set based on the average contamination proportions of the study sites over the previous year. If additional study sites included, we will plan to enroll 650 paired blood culture sets assuming a baseline contamination proportion of 1.8%.

Statistical analysis: We will declare noninferiority if the upper limit of the 1-sided 95% interval for the difference in proportions of contamination (the proportion of contamination in arterial catheter blood cultures minus the proportion of contamination in skin puncture blood cultures) is less than the noninferiority margin of 2%. As a pre-specified secondary analysis, we will examine the difference between collected blood volumes in arterial catheter blood cultures and in skin puncture blood cultures with t-test or nonparametric test.

Management information
Registered date
2018 Year 12 Month 28 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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