UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Quality of life after hospital discharge in elder critically ill patients: observational study
Title of the study (Brief title)	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	Tomoaki Yatabe
Organization	Kochi Medical School
Division name	Intensive Care Unit
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	Tomoaki Yatabe
Organization	Kochi Medical School
Division name	Intensive Care Unit
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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