UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008725 |
|---|---|
| Receipt number | R000009983 |
| Scientific Title | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2014/08/26 08:59:46 |
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Basic information
Public title
Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients.
Acronym
Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients.
Scientific Title
Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients.
Scientific Title:Acronym
Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients.
Region
| Japan |
Condition
Condition
Intravascular catheter colonization.
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness for prevention of central venous and arterial catheter colonization of 3 skin antisepsis: 10% aqueous povidone iodine, 1% alcoholic chlorhexidine gluconate, and 0.5% alcoholic chlorhexidine gluconate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of catheter colonization per 1000 catheter days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection.
Interventions/Control_2
Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection.
Interventions/Control_3
Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection.
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
All consecutive central venous and arterial catheters inserted into patients in the ICU.
Key exclusion criteria
The catheters inserted into patients who were less than 18 years of age.
The catheters removed within less than 72 hour of their insertion.
The catheters inserted for long-term total parenteral nutrition or chemotherapy.
A patient with the allergy to an antiseptic.
The catheters inserted with the use of a guidewire.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideto Yasuda |
Organization
Japanese Red Cross Musashino Hospital
Division name
Emergency and Critical Care Medicine
Zip code
Address
1-26-1 kyounanchou, musashinoshi, tokyo, Japan
TEL
0422-32-3111
yasudahideto@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideto Yasuda |
Organization
Japanese Red Cross Musashino Hospital
Division name
Emergency and Critical Care Medicine
Zip code
Address
1-26-1 kyounanchou, musashinoshi, tokyo, Japan
TEL
0422-32-3111
Homepage URL
yasudahideto@me.com
Sponsor or person
Institute
Nonprofit Organization Japanese Society of Education for Physicians and Trainees in Intensive Care
Institute
Department
Personal name
Funding Source
Organization
Yoshida Pharmaceutical
Maruishi Pharmaceutical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 09 | Month | 01 | 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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009983
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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