UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000045624
Receipt No. R000052088
Scientific Title AAEM multicentre retrospective study
Date of disclosure of the study information 2021/10/01
Last modified on 2021/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Acronym Investigation of the association between early rehabilitation and patient outcomes in intensive care units: a multicentre retrospective study
Scientific Title AAEM multicentre retrospective study
Scientific Title:Acronym AAEM multicentre retrospective study
Region
Japan

Condition
Condition ICU patients
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to investigate the relationship between PICS and patient outcomes using the Euro QOL 5 Dimension (EQ-5D-5L) as a surrogate outcome by investigating the actual release (frequency and intensity) in a multi-centre setting where standard rehabilitation is provided.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Euro-QOL at discharge from hospital (EQ-5D-5L)
Key secondary outcomes

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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria All patients admitted to the ICU in a certain 2-month period
Key exclusion criteria (1) Under 18 years old
2) Patients who are expected to be discharged from ICU within 48 hours (e.g., follow-up after scheduled surgery, dialysis only)
3) Diseases presenting central nervous system disorder (stroke, severe head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary resuscitation with hypoxic encephalopathy, cervical cord injury with consciousness disorder, cerebrovascular dementia, Alzheimer's disease, Parkinson's disease, etc.)
(4) Patients who have difficulty in communicating in Japanese and cooperating in rehabilitation, such as foreigners (including schizophrenia, anxiety neurosis, depression, autism, etc.)
(5) Patients who were unable to walk even with the use of assistive devices before admission (using services requiring nursing care 3 or more: standard)
6) End of life/Terminal care cases where treatment is not the aim
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Fujizuka
Organization Japan Red Cross Maebashi Hospital
Division name Advanced Medical Emergency Department and Critical Care Center
Zip code 371-0811
Address 389-1 Asakura-cho, Maebashi-shi, Gunma
TEL +81272653333
Email fujiken_sanjo_4138@yahoo.co.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Fujizuka
Organization Japan Red Cross Maebashi Hospital
Division name Advanced Medical Emergency Department and Critical Care Center
Zip code 371-0811
Address 389-1 Asakura-cho, Maebashi-shi, Gunma
TEL +81272653333
Homepage URL
Email fujiken_sanjo_4138@yahoo.co.jp

Sponsor
Institute Japan Red Cross Maebashi Hospital
Advanced Medical Emergency Department and Critical Care Center
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Red Cross Maebashi Hospital
Address 389-1 Asakura-cho, Maebashi-shi, Gunma
Tel +81 27-265-3333
Email fujiken_sanjo_4138@yahoo.co.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
2021 Year 10 Month 01 Day

Related information
URL releasing protocol not available
Publication of results Unpublished

Result
URL related to results and publications not available
Number of participants that the trial has enrolled 200
Results Under analysis
Results date posted
2021 Year 10 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Under analysis
Participant flow Under analysis
Adverse events Under analysis
Outcome measures Under analysis
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2019 Year 06 Month 15 Day
Date of IRB
2019 Year 07 Month 05 Day
Anticipated trial start date
2019 Year 10 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular at this moment

Management information
Registered date
2021 Year 10 Month 01 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052088

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.