UMIN-CTR Clinical Trial

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

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
Obstetrics and Gynecology	Urology	Anesthesiology
Intensive care medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

catheter-related blood steam infection

Key secondary outcomes

cases in which catheter is removed due to suspicious catheter-related blood steam infection

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Hospital Organization

Institute

Department

Personal name

Organization

National Hospital Organization

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2009

Year

12

Month

09

Day

Last modified on

2015

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003493