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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002300
Receipt No. R000002809
Scientific Title A prospective clinical study of venous arterial blood manipulation system on prevention with arterial line contamination in critically ill patients.
Date of disclosure of the study information 2009/08/06
Last modified on 2011/08/06

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Basic information
Public title A prospective clinical study of venous arterial blood manipulation system on prevention with arterial line contamination in critically ill patients.
Acronym Venous arterial blood manipulation system and atrial line contamination.
Scientific Title A prospective clinical study of venous arterial blood manipulation system on prevention with arterial line contamination in critically ill patients.
Scientific Title:Acronym Venous arterial blood manipulation system and atrial line contamination.
Region
Japan

Condition
Condition Critically ill patients
Classification by specialty
Infectious disease Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate if the venous arterial blood manupulation system reduce intraluminal arterial catheter contamination when compared to a conventional three-way stopcock.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The intraluminal contamination rate of arterial line.
Key secondary outcomes The rate of arterial catheter-related bloood stream infection

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Use of venous arterial blood manipulation system for arterial line.
Interventions/Control_2 Use of conventional three-way stopkock for arterial line.
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 Critically ill patients with arterial line for more than 24 hours.
Key exclusion criteria Accidental removal of the catheter
Use of <24 h or no aspiration of blood through the arterial line.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Oto
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramoto-cho Tokushima city Tokushima Japan
TEL 088-633-9347
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Oto
Organization Emergency and Critical Care Medicine
Division name 3-18-15 Kuramoto-cho Tokushima city Tokushima Japan
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Emergency and Critical Care Medicine Tokushima University Hospital
Institute
Department

Funding Source
Organization Emergency and Critical Care Medicine Tokushima University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
We analyzed microbial contamination for a total of 216 arterial catheters: 109 in the test group and 107 in the comparator group. We found no difference in the incidence of catheter-tip colonization in the two groups (test group 8/109 vs. comparator group 11/107, P = 0.48). There was a statistically significant correlation between catheter-tip colonization and duration of arterial line utilization. We found statistically significantly lower intraluminal fluid contamination in the test group (test group 2/109 vs. comparator group 9/107, P = 0.03). There was no relationship between intraluminal fluid contamination and catheter-tip contamination.
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 Completed
Date of protocol fixation
2009 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 03 Month 01 Day
Date trial data considered complete
2011 Year 03 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 05 Day
Last modified on
2011 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002809

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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