UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031917
Receipt No. R000034017
Scientific Title Quality of life after hospital discharge in elder critically ill patients: observational study
Date of disclosure of the study information 2018/04/01
Last modified on 2018/03/27

* 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 Quality of life after hospital discharge in elder critically ill patients: observational study
Acronym Quality of life after hospital discharge in elder critically ill patients
Scientific Title Quality of life after hospital discharge in elder critically ill patients: observational study
Scientific Title:Acronym Quality of life after hospital discharge in elder critically ill patients
Region
Japan

Condition
Condition Critically ill patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify mortality and quality of life after 6 month in elderly post intensive care patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Quality of life after 6 month
Key secondary outcomes Mortality after 6 month

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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Survivor patients who received mechanical ventilation for at least 24 hours and were in the ICU for >48 hours
Key exclusion criteria 1) Second or subsequent readmission to the ICU during the study period
2) Patients who are difficult to answer in the questionnaire form
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Yatabe
Organization Kochi Medical School
Division name Intensive Care Unit
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan
TEL 088-880-2471
Email yatabe@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Yatabe
Organization Kochi Medical School
Division name Intensive Care Unit
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi, 783-8505, Japan
TEL 088-880-2471
Homepage URL
Email yatabe@kochi-u.ac.jp

Sponsor
Institute Intensive Care Unit, Kochi Medical School Hospital
Institute
Department

Funding Source
Organization Kochi University President Discretionary Grant
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
Address
Tel
Email

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
2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2017 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)Age, Gender, Height, Weight
2)Reasons for ICU admission, length of ICU stay, outcome at ICU discharge
3)Length of hospital stay, outcome at hospital discharge, destination
4)Physical status (bed rest, wheelchair, or walking) one week prior to ICU admission
5)Marital status,comorbidity
6)APACHE II,SOFA, Alb at ICU admission
7)Date of the start of rehabilitation, rehabilitation status (bed rest, sitting, end sitting, sitting on wheelchair, or walking) at hospital discharge, hand grip
8)Date of the start of oral or enteral nutrition
9)Caloric and protein intake in the ICU on day 7 and the day before hospital discharge
10)6 month mortality
11)Quality of life measured the WHODAS ver 2.0 after 6 month

Management information
Registered date
2018 Year 03 Month 27 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034017

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.