UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Frequency and the risk factors of ICU-AW after critical illness
Title of the study (Brief title)	Frequency and the risk factors of ICU-AW after critical illness
Region	Japan

Condition
Condition	ICU acquired weakness
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the frequency and prognosis of ICU-AW in critically ill patients admitted to ICU
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the rate of ICU-AW and the time when nerve conduction study has changed
Key secondary outcomes	prognosis(ICU, 28day, 90day, hospital mortality) inflamatory biomarker(CRP, Procalcitonin, Presepsin) Plasma cytokine(IL-1, IL-4, IL-6, IL-8, IL-10, IFN-gamma, TNF-alpha) Steroid, Immunoglobulin, Sedatives day of the beginning of rehabilitation, period of rehabilitation

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	The patients with mechanical ventilation over 18 years old over 24 hours length of stay of ICU The patiens with highly invasive or organ failure due to infection The patient who got agreement on this study
Key exclusion criteria	The patients who didn't got agreement on this study The patients judged as inappropriate enrollment
Target sample size	50

Research contact person
Name of lead principal investigator	Masayuki Akatsuka
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	m_a_let_go@yahoo.co.jp

Public contact
Name of contact person	Masayuki Akatsuka
Organization	Sapporo Medical University School of Medicene
Division name	Department of Intensive Care Medicine
Address	South1 West16, Chuo-ku, Sapporo
TEL	011-611-2111
Homepage URL
Email	m_a_let_go@yahoo.co.jp

Sponsor
Institute	Sapporo Medical University School of Medicene, Department of Intensive Care Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicene, Department of Intensive Care Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 12 Month 19 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 14 Day
Anticipated trial start date	2017 Year 12 Month 18 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	Investigation of the timing of abnormalities of nerve conduction study in the patients with ICU-AW and clarification of the risk factors.

Management information
Registered date	2017 Year 12 Month 19 Day
Last modified on	2017 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034662