UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037492 |
|---|---|
| Receipt number | R000042719 |
| Scientific Title | Effect of prophylaxis using 1% chlorhexidine gluconate and chlorhexidine-gel-impregnated dressings on central venous catheter-related thrombosis and infections in critically ill patients: a retrospective observational study. |
| Date of disclosure of the study information | 2019/07/25 |
| Last modified on | 2019/07/25 17:04:26 |
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Basic information
Public title
Study using chlorhexidine on catheter related thrombosis and infections.
Acronym
Study using chlorhexidine on catheter related thrombosis and infections.
Scientific Title
Effect of prophylaxis using 1% chlorhexidine gluconate and chlorhexidine-gel-impregnated dressings on central venous catheter-related thrombosis and infections in critically ill patients: a retrospective observational study.
Scientific Title:Acronym
Study using chlorhexidine on catheter related thrombosis and infections.
Region
| Japan |
Condition
Condition
Patients who required central venous catheter for more than 48 hours in intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to determine the prophylactic effect of a 1% alcoholic chlorhexidine gluconate and chlorhexidine-gel-impregnated dressing combination on catheter-related thrombosis, which is a known risk factor for catheter-related bloodstream infections, in critically ill patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Catheter-related thrombosis within 14 days of catheter insertion
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
We included patients who required central venous catheter (CVC) for more than 48 hours in the intensive care unit(ICU). Patients whose CVCs were inserted in the ICU or operating room were included. Catheters inserted via the internal jugular vein were included. 12-gauge triple lumina CVCs were used.
Key exclusion criteria
We excluded patients who were inserted in places outside the intensive care unit (ICU) or operating room, or whose catheters inserted via the subclavian or femoral veins, or who were less than 48 hours in ICU, or who had a history of hypersensitivity for chlorhexidine.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Intensive Care Unit
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga City, Saga, Japan.
TEL
0952-34-2324
yamadato@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Yamashita |
Organization
Saga University Hospital
Division name
Intensive Care Unit
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga City, Saga, Japan.
TEL
0952-34-2324
Homepage URL
yamadato@cc.saga-u.ac.jp
Sponsor or person
Institute
Intensive Care Unit, Saga University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Saga University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Center, Saga University Hospital
Address
5-1-1, Nabeshima, Saga City, Saga, Japan.
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.ac.jp
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
| 2019 | Year | 07 | Month | 25 | 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
134
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
| 2014 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We included all patients who matched the inclusion criteria, who managed in the intensive care unit between November 2009-December 2010 and September 2012-December 2014, in this study.
Management information
Registered date
| 2019 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042719
