UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002300 |
|---|---|
| Receipt number | 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 10:36:47 |
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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
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
Sponsor or person
Institute
Emergency and Critical Care Medicine Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002809
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
