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

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

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 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

Email

kenkyu-shinsei@ml.cc.saga-u.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name