UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031917 |
|---|---|
| Receipt number | 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 09:50:04 |
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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
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
yatabe@kochi-u.ac.jp
Sponsor or person
Institute
Intensive Care Unit, Kochi Medical School Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
