UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028686
Receipt number 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 2023/02/26 23:03:28

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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 or person

Institute

Fukuyama City Hospital
Department of Anesthesiology

Institute

Department

Personal name



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

Main results already published

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

2023 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032822