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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002865
Receipt No. R000003493
Scientific Title Risk factors of catheter-related blood stream infection in non-tunneled central venous catheter
Date of disclosure of the study information 2009/12/11
Last modified on 2015/04/06

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Basic information
Public title Risk factors of catheter-related blood stream infection in non-tunneled central venous catheter
Acronym IVH study
Scientific Title Risk factors of catheter-related blood stream infection in non-tunneled central venous catheter
Scientific Title:Acronym IVH study
Region
Japan

Condition
Condition Any conditions requiring central venous catheter in general hospitals (adult patients)
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Infectious disease Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Obsterics and gynecology Urology Anesthesiology
Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Catheter-related blood stream infection (CRBSI) following insertion of central venous catheter (CVC) can be fatal complication which results in huge medical expense. According to the Guidelines for the prevention of intravascular catheter-related infections issued by Centers for Disease Control and Prevention, use of maximal sterile barrier precautions (MSBPs) during CVC insertion, using a cap, mask, sterile gown, sterile gloves, and a large sterile sheet, was recommended as category IA. However, our multi-center randomized controlled trial demonstrated that there was no difference of CRBSI rates between MSBPs and standard sterile barrier precautions (SSBPs) groups. The guideline also recommended use of 2% chlorhexidine solution for skin hygiene on CVC insertion but use of the dose is prohibited in Japan. Therefore, we should not blindly obey the CDC guideline in Japan and should create our own prevention strategy in our clinical settings.
This study was undertaken to elucidate risk factors of CRBSI following CVC insertion and to establish its prevention strategy in Japan.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes catheter-related blood steam infection
Key secondary outcomes cases in which catheter is removed due to suspicious catheter-related blood steam infection

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
19 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Any patients over 19 years old who required non-tunneled central venous catheter.
Key exclusion criteria 1) patients who are under 18 years old
2) patients who have high fever over 38.1 cent degree
3) patients who were already administered antibiotics
4) patients who already had central venous catheter
5) patients who do not sign a consent form
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaharu Odo
Organization National Hospital Organization Kumamoto Medical Center
Division name Department of Surgery
Zip code
Address 1-5 Ninomaru, Kumamoto 8600008, Japan
TEL 096-353-6501
Email epass2006@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Haga
Organization National Hospital Organization Kumamoto Medical Center
Division name Institute for Clinical Research
Zip code
Address 1-5 Ninomaru, Kumamoto 8600008, Japan
TEL 096-353-6501
Homepage URL
Email yoshio@kumamed.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding 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
2009 Year 12 Month 11 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Background: Risk factors for catheter-related bloodstream infections (CRBSIs) may change over time with progress in infection control. This study was undertaken to explore the current risk factors for CRBSIs in hospitalized patients. 

Methods: Adult patients with non-tunneled central venous catheters (CVCs) in 12 Japanese referral hospitals were prospectively enrolled between December 2009 and January 2012. Patients were monitored for CRBSIs for up to 8 weeks from CVC insertion; data were collected regarding patient characteristics, the purpose of CVC insertion, insertion methods, mechanical complications during insertion, and post-insertion catheter care. 

Results: A total of 892 patients were enrolled in this study. The overall incidence of CRBSIs was 0.40 infections per 1000 catheter-days. Univariate analysis using the Fisher's exact test identified one of the participating hospitals (hospital A; p < 0.001), internal jugular vein catheterization (IJVC) (p = 0.0013), not using maximal sterile barrier precautions (p = 0.030), and the Seldinger technique for catheter insertion (p = 0.025) as significant risk factors for CRBSI. After excluding data from hospital A, only IJVC remained a significant risk factor for CRBSI (p = 0.025). The cumulative probability of remaining without CRBSI was significantly lower in patients with IJVCs than in patients with other catheter routes (p < 0.001; log-rank test). Similarly, the cumulative probability of remaining without catheter removal due to a suspected infection was significantly lower in patients with IJVCs (p = 0.034; log-rank test). 

Conclusions: The current study suggests that IJVC might be a risk factor for CRBSI under current infection control conditions.

This article was published online in Scand J Infect Dis.

Read More: http://informahealthcare.com/doi/abs/10.3109/00365548.2013.807936
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
2009 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 13 Day
Date analysis concluded

Other
Other related information 1. Study design: multi-center prospective cohort study
2. Data collection
A. Variables to be investigated
1) Baseline data: age, gender, primary disease, co-morbidity, type of ward, department
2) Purpose of CVC insertion
3) Site of CVC insertion
4) Skin hygiene method on CVC insertion
5) Type of sterile barrier precaution: MSBPs or SSBPs
6) How to puncture vein: direct puncture or Seldinger method; ultrasound-guided or not
7) Number of punctures on insertion
8) Number of lumen of catheter
9) Complications on insertion
10) Dressing methods
11) Duration of dressing change
12) Skin hygiene method on dressing change
13) Presence or absence of antibiotics administration during observation
14) Type of line connector system: open or closed
15) Presence or absence of in-line filter
16) Duration of catheterization
17) Reason for catheter removal
18) Type of microorganisms detected by blood cultures
B. Observational period: All patients were observed until the catheter was removed or until 8 weeks after catheterization.
3. Statistical analysis
1) Significant variables demonstrating significant differences of the incidences of primary endpoint will be identified using chi-square tests.
2) Using these significant variables, independent factors which associate with primary endpoint will be identified via a logistic regression analysis.
3) Based on these results, we will establish prevention strategy for catheter-related blood stream infection.

Management information
Registered date
2009 Year 12 Month 09 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003493

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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