UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005438 |
|---|---|
| Receipt number | R000006452 |
| Scientific Title | prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters |
| Date of disclosure of the study information | 2011/04/14 |
| Last modified on | 2011/04/14 16:12:12 |
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Basic information
Public title
prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters
Acronym
prospective study of prevention of infections for patients with tunneled central venous catheters
Scientific Title
prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters
Scientific Title:Acronym
prospective study of prevention of infections for patients with tunneled central venous catheters
Region
| Japan |
Condition
Condition
patients with pulmonary arterial hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis of safety and efficacy of chlorhexidine-impregnated sponge dressing for infection control in patients with pulmonary arterial hypertension who receiving prostacyclin continuous infusion therapy by using tunneled CV catheter
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of catheter related infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of chlorhexidine-impregnated sponge dressing during former 6 months
Interventions/Control_2
Use of chlorhexidine-impregnated sponge dressing during latter 6 months
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
Patient diagnosed as pulmonary arterial hypertension (Class 1 in Dana Point Classification), and receiving prostacyclin continuous infusion therapy by using tunneled CY catheter
Key exclusion criteria
1. Patient affected with catheter related infection within this 1 month.
2. Patient with acute right heart failure
3. Receiving home oxygen therapy
4. Patient who has already committing other infection control therapies
5. Patient with allergy to chlorhexidine
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Tamura |
Organization
Keio University School of Medicine
Division name
Department of cardiology
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Tamura |
Organization
Keio University School of Medicine
Division name
Department of cardiology
Zip code
Address
TEL
Homepage URL
u1@ta-mu.net
Sponsor or person
Institute
Department of cardiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of cardiology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
慶應義塾大学病院(東京都)
杏林大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 14 | Day |
Last modified on
| 2011 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006452
