UMIN-CTR Clinical Trial

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
Email	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
Email	yamadato@cc.saga-u.ac.jp

Sponsor
Institute	Intensive Care Unit, Saga University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042719

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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