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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008725
Receipt No. 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

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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
Email 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
Email yasudahideto@me.com

Sponsor
Institute Nonprofit Organization Japanese Society of Education for Physicians and Trainees in Intensive Care
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009983

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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