UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036503 |
|---|---|
| Receipt number | R000041241 |
| Scientific Title | Early mobilization and post intensive care syndrome for critically ill patients in the ICU: multi-center, prospective observational study |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/10/13 12:42:45 |
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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
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
billabonghonor@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization, Nagoya Medical center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041241
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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