UMIN-CTR Clinical Trial

Basic information
Public title	Early mobilization and post intensive care syndrome for critically ill patients in the ICU: multi-center, prospective observational study
Acronym	Early mobilization and post intensive care syndrome for critically ill patients: multi-center, prospective observational study (EM-PICS study)
Scientific Title	Early mobilization and post intensive care syndrome for critically ill patients in the ICU: multi-center, prospective observational study
Scientific Title:Acronym	Early mobilization and post intensive care syndrome for critically ill patients: multi-center, prospective observational study (EM-PICS study)
Region	Japan

Condition
Condition	Critically ill patients who are expected to enter in intensive care unit for more than 48 hours.
Classification by specialty	Intensive care medicine Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between the early mobilization in Japanese intensive care unit and the onset of postintensive care syndrome.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	prevalence of PICS and PICS-F.
Key secondary outcomes	90-day mortality, ICU length of stay, Hospital length of stay, incidence of delirium, incidence of ICU-acquied weakness, duration of mechanical ventilation, activity daily living level, Mobility related items

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients newly admitted in ICU
Key exclusion criteria	Age < 18 years, Patients expected to discharge the ICU within 48 hours, Neurological patients, Patients who are difficult to cooperate in communication and rehabilitation in Japanese, Patients who could not independently able to mobilize prior to the current hospital admission, Treatment is not aimed end of life/terminal care patients
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Yasunari Middle name Last name Morita
Organization	National Hospital Organization, Nagoya Medical center
Division name	Department of Emergency and Critical Care Medicine
Zip code	460-0001
Address	4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan.
TEL	052-951-1111
Email	moltlyme2@yahoo.co.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Watanabe
Organization	National Hospital Organization, Nagoya Medical center
Division name	Department of Rehabilitation Medicine
Zip code	460-0001
Address	4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan.
TEL	052-951-1111
Homepage URL
Email	billabonghonor@yahoo.co.jp

Sponsor
Institute	National Hospital Organization, Nagoya Medical center
Institute
Department

Funding Source
Organization	Japanese Association for Acute Medicine
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	National Hospital Organization, Nagoya Medical center
Address	4-1-1 Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan.
Tel	0529511111
Email	billabonghonor@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	2019 Year 06 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	Completed
Date of protocol fixation	2019 Year 06 Month 01 Day
Date of IRB	2019 Year 05 Month 15 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry	2020 Year 07 Month 01 Day
Date trial data considered complete	2020 Year 12 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other

Other related information

(Basic information) Age, male, height, weight, admission route, Charson Index, presence or absence of dialysis, main cause of ICU admission, sepsis, diabetes, Acute physiology and chronic health evaluation, Sequential organ failure assessment, Drug use at ICU, Extracorporeal membrane oxygenation: With or without (Rehabilitation information during ICU admission) Assessment of respiration during rehabilitation: use of mechanical ventilator, oral intubation, tracheotomy. Assessment of circulation during rehabilitation: use of catecholamine, DOA, DOB, NAD, Epinephrine, Vasopressin. Assessment of consciousness delirium during rehabilitation With or without the use of persistent analgesics and sedatives, with pain just before rehabilitation, incidence of delirium. Other items during rehabilitation: Enteral feeding tube, chest tube, abdominal tube, urine balloon, arterial line, central venous line, presence of drip in inguinal region Releasing related items in ICU: highest movement level in rehabilitation, nurses participating in rehabilitation, physician, physiotherapist, number of other occupations, ICU mobility scale; achieving IMS Level 3 or higher, IMS Level 3 or higher Cause that was not Non-rehabilitation interventions in ICU: ABCEDFGHI Bundle. Adverse events during rehabilitation (Patient outcome information) Length of Hospital days, length of ICU days, duration of ventilator, early mobilization related items, Discharge at Barthel Index, Discharge at Medical Research Council sum-score, Discharge at hospital hand grip strength, Hospital Anxiety and Depressions (HADS) at hospital discharge, impact on event scale -reverd (IES-R) at hospital duscharge, EQ-5D-5L at hospital discharge, EQ-5D-5L at after 90 days, HADS at after 90 days, IES-R at after 90 days, HADS of patient family at after 90 days, IES-R of patient family at after 90 days

Management information
Registered date	2019 Year 04 Month 13 Day
Last modified on	2020 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041241