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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028686
Receipt No. R000032822
Scientific Title The effect of expanded applied contact precaution in Mixed Intensive Care Unit of Surgical & Internal medicine: a prospective observational study
Date of disclosure of the study information 2017/08/16
Last modified on 2019/12/03

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Basic information
Public title The effect of expanded applied contact precaution in Mixed Intensive Care Unit of Surgical & Internal medicine: a prospective observational study
Acronym Expanded applied contact precaution in Mixed ICU
Scientific Title The effect of expanded applied contact precaution in Mixed Intensive Care Unit of Surgical & Internal medicine: a prospective observational study
Scientific Title:Acronym Expanded applied contact precaution in Mixed ICU
Region
Japan

Condition
Condition Critically Ill Patients in Intensive Care Unit
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We have started our own rules of expanded applied contact precaution in our Intensive Care Unit (ICU). The aim of this study is assessment of effective of these rules.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary Outcome is the incidence of newly acquired MRSA in ICU.
Key secondary outcomes Secondary Outcomes are the incidence of newly acquired MRSA for 30 days after discharge from ICU, and the incidence of newly acquired multidrug-resistant bacteria in the patients who adapted our rules during ICU stay.

The rules we made were to apply contact precaution not only to patients who had multidrug-resistant bacteria, but also to patients who entered ICU emergency, patients with history of infection of multidrug-resistant bacteria and patients who had to stay in ICU for a long time. Another rules started from this study period were to avoid using shared items among patients as much as possible (use disposable items), and to use a method that all of the patients had to been touched with properly disinfected "clean hands" without hand roughness. Data of patients who admitted in our ICU from May 2013 to December 2015 were used as Historical Control.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All patients who admit between July 2016 and December 2016 are studied.
Key exclusion criteria none
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Kenzo
Middle name
Last name Ishii
Organization Fukuyama City Hospital
Division name Department of Anesthesiology, Intensive care unit
Zip code 721-8511
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
TEL 084-941-5151
Email keishii1101@gmail.com

Public contact
Name of contact person
1st name Kenzo
Middle name
Last name Ishii
Organization Fukuyama City Hospital
Division name Department of Anesthesiology, Intensive care unit
Zip code 721-8511
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
TEL 084-941-5151
Homepage URL
Email keishii1101@gmail.com

Sponsor
Institute Fukuyama City Hospital
Department of Anesthesiology
Institute
Department

Funding Source
Organization Fukuyama City Hospital
Department of Anesthesiology
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 IRB, Fukuyama City Hospital
Address 5-23-1 zao-cho, Fukuyama, Hiroshima, Japan
Tel 084-941-5151
Email shimin-byouin@city.fukuyama.hiroshima.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
2017 Year 08 Month 16 Day

Related information
URL releasing protocol Unpublished
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 577
Results
There was no significant difference in the incidence compared to historical control (1.3 vs. 1.4 cases per 1,000 patient days).  However, there was significant difference in the incidence of newly acquired multi-drug resistant bacteria between patients who adapted our rules of contact precautions and patients who did not adapted them (ex. after scheduled operation) (12.26 vs. 3.24 cases per 1,000 patient days).
Results date posted
2019 Year 12 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We analyzed 577 ICU cases in study period, and 2 cases had newly acquired MRSA.
Participant flow
All patients who admitted between July 2016 and December 2016 were studied. The rules we made were to apply contact precaution not only to patients who had multidrug-resistant bacteria, but also to patients who entered ICU emergency, patients with history of infection of multidrug-resistant bacteria and patients who had to stay in ICU for a long time.
Adverse events
None
Outcome measures
Primary Outcome was the incidence of newly acquired MRSA in ICU. Secondary Outcomes were the incidence of newly acquired MRSA for 30 days after discharge from ICU, and the incidence of newly acquired multidrug-resistant bacteria in the patients who adapted our rules during ICU stay.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 06 Month 30 Day
Date of IRB
2016 Year 06 Month 30 Day
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2017 Year 01 Month 31 Day
Date of closure to data entry
2017 Year 03 Month 31 Day
Date trial data considered complete
2017 Year 10 Month 31 Day
Date analysis concluded

Other
Other related information Data collection is over.
We are analyzing these data now.

Management information
Registered date
2017 Year 08 Month 16 Day
Last modified on
2019 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032822

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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