UMIN-CTR Clinical Trial

Basic information
Public title	An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Acronym	An observational study for epidemiology and treatment strategy for PICS
Scientific Title	An observational study for prevalence of post-intensive care syndrome in patients and their families after ICU treatment and the identification of possibilities for prevention and treatment.
Scientific Title:Acronym	An observational study for epidemiology and treatment strategy for PICS
Region	Japan

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

Objectives
Narrative objectives1	This study aims at describing the prevalence of post-ICU syndrome (PICS) in patients treated under limited family contact, using patient information and questionnaires. The study will continue after family visits are freed, and will observer the difference between the two phases. the study will also attempt to identify possible prevention strategy for PICS.
Basic objectives2	Others
Basic objectives -Others	study of epidemiology
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The effect of limited family visits on the prevalence of PICS
Key secondary outcomes	The overall prevalence of PICS in ICU patients The effect of severity and treatment on the occurrence of PICS The effect of family involvement on PICS

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Age 20 years and older 2. ICU treatment more than 3 days
Key exclusion criteria	1. age under 20 years 2. less than 3 days in ICU 3. patients after elective surgery 4. others decided by investigators
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Taka-aki Middle name Last name Nakada
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Zip code	260-8677
Address	1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL	043-226-2341
Email	chibadaieccm-office@umin.ac.jp

Public contact
Name of contact person	1st name Taku Middle name Last name Oshima
Organization	Chiba University Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
Zip code	260-8677
Address	1-8-1 Inohana Chuo-ku, Chiba City, Chiba
TEL	043-226-2341
Homepage URL
Email	t_oshima@chiba-u.jp

Sponsor
Institute	Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Emergency and Critical Care Medicine, Chiba University Graduate School of Medicine
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	Institutional Review Board, Chiba University Graduate School of Medicine
Address	1-8-1 Inohana Chuo-ku, Chiba City, Chiba
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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	2020 Year 10 Month 19 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	Enrolling by invitation
Date of protocol fixation	2020 Year 05 Month 28 Day
Date of IRB	2020 Year 05 Month 28 Day
Anticipated trial start date	2020 Year 10 Month 12 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2020 Year 10 Month 19 Day
Last modified on	2020 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048121