UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002733 |
|---|---|
| Receipt number | R000003312 |
| Scientific Title | Safety evaluation of the closed circuit of arterial pressure monitoring |
| Date of disclosure of the study information | 2009/11/09 |
| Last modified on | 2009/11/09 18:58:40 |
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Basic information
Public title
Safety evaluation of the closed circuit of arterial pressure monitoring
Acronym
SECC
Scientific Title
Safety evaluation of the closed circuit of arterial pressure monitoring
Scientific Title:Acronym
SECC
Region
| Japan |
Condition
Condition
All diseases
Classification by specialty
| Medicine in general | Surgery in general | Orthopedics |
| Urology | Neurosurgery | Cardiovascular surgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of the microbial barrier in a closed system of arterial catheter
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rate of the identical bacterial strain from both the hub and the blood samples
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To use a closed system of arterial catheter
Interventions/Control_2
To use an open system of arterial catheter
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
Patients who are expected to stay in ICU for three days or more and requires an arterial catheter insertion.
Key exclusion criteria
Patients whose blood culture results were positive before admission
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Katsuragi |
Organization
Keio University Hospital
Division name
Department of Nursing
Zip code
Address
35 Shinanomachi Shinjuku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University Hospital
Division name
General Intensive Care Unit
Zip code
Address
TEL
03-3353-1211
Homepage URL
Sponsor or person
Institute
General Intensive Care Unit in Keio University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia Keio University School of Medicine
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 | 11 | 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
| 2009 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 09 | Day |
Last modified on
| 2009 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003312
