UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059037 |
|---|---|
| Receipt number | R000067519 |
| Scientific Title | A Single-center Prospective Comparison Study of Blood Culture Contamination Rates Between Peripheral Venipuncture and Non-wire Hub Collection During Central Venous Catheter Insertion in Critically ill Patients: Bayesian sequential design |
| Date of disclosure of the study information | 2025/09/09 |
| Last modified on | 2025/09/10 12:15:13 |
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Basic information
Public title
A Single-center Prospective Comparison Study of Blood Culture Contamination Rates Between Peripheral Venipuncture and Non-wire Hub Collection During Central Venous Catheter Insertion in Critically ill Patients
Acronym
Blood Culture Contamination Rates Between Non-wire Hub Collection and Peripheral Venipuncture
Scientific Title
A Single-center Prospective Comparison Study of Blood Culture Contamination Rates Between Peripheral Venipuncture and Non-wire Hub Collection During Central Venous Catheter Insertion in Critically ill Patients: Bayesian sequential design
Scientific Title:Acronym
Contamination of Blood Culture: Venipuncture vs Non-wire hub during Central line insertion
Region
| Japan |
Condition
Condition
Blood Culture Contamination
Classification by specialty
| Infectious disease | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to estimate the excess contamination rate (delta) in blood cultures obtained from lumens without wire manipulation (non-wire hubs) during new central venous catheter insertion compared to peripheral venous puncture. The results of this study will provide the basis for finalizing the design of subsequent confirmatory trials.
Basic objectives2
Others
Basic objectives -Others
The secondary objective is to collect statistical evidence to determine whether delta falls within a clinically acceptable range relative to the pre-specified non-inferiority margin (2.0%) (non-inferiority) or clearly exceeds it (superiority).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood culture contamination rates during central venous catheter insertion and venipuncture
Key secondary outcomes
True bacteremia rate
Positive Agreement Rate
Obtained volume of blood culture
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients suspected of having an infection by a clinician who require blood culture collection and central venous catheter placement
Adults aged 18 years and older
Key exclusion criteria
Individuals who declined to participate in the research
Individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Hasegawa |
Organization
Sakai City Medical Center
Division name
Department of infectious diseaseas
Zip code
593-8304
Address
1-1-1, Ebaraji-cho, nishi-ku, Sakai, Osaka
TEL
072-272-1199
ipph86txs@gmail.com
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Hasegawa |
Organization
Sakai City Medical Center
Division name
Department of infectious diseases
Zip code
593-8304
Address
1-1-1, Ebaraji-cho, nishi-ku, Sakai, Osaka
TEL
09098701250
Homepage URL
ipph86txs@gmail.com
Sponsor or person
Institute
Sakai City Medical Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakai City Medical Center
Address
1-1-1, Ebaraji-cho, nishi-ku, Sakai, Osaka
Tel
072-272-1199
ipph86txs@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, two-group paired comparison clinical trial using a Bayesian sequential design, in which blood cultures are collected simultaneously from two pathways, a nonwire hub and a peripheral vein, in the same patient.
Case registration will be promptly terminated upon meeting any of the predefined discontinuation criteria.
Maximum Sample Size: Case registration for this study will be limited to a maximum of one year from the study start date. Preliminary estimates project approximately 280 cases within one year. Due to anticipated seasonal variations in blood culture positivity rates and contamination incidence, the study period is set to a maximum of one year to minimize bias related to the timing of study implementation.
Interim Monitoring: Interim monitoring will be conducted after the initial 100 pairs are enrolled and every 30 additional pairs of data are accumulated thereafter.
Study Termination Criteria: At each interim monitoring point, the 95% confidence interval for delta will be calculated.
Management information
Registered date
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067519
