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
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
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
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
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