UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	NEuromuscular pathology in CRitically ill patients: an autOPSY Study "NECROPSY Study"
Title of the study (Brief title)	NECROPSY Study
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 neuropathic and myopathic change by postmortem examination in critically ill patients
Basic objectives2	Others
Basic objectives -Others	To clarify neuropathic and myopathic change by postmortem examination in critically ill patients
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	a degree and frequency of pathologic abnormality of peripheral nerve and muscle in critically ill patients
Key secondary outcomes	relationship between pathologic abnormality and muscle weakness, clinical diagnosis, severity, and medication

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	adult patients who undergo mechanical ventilation for more than 72 hours and die during mechanical ventilation or within 2 weeks after weaning from the ventilator
Key exclusion criteria	patients who have exogenous disease such as poisoning or trauma, central nervous system disease, and medical history of neuropathy and/or myopathy
Target sample size	50

Research contact person
Name of lead principal investigator	Tetsuhiro TAKEI
Organization	Yokohama City Minato Red Cross Hospital
Division name	Department of Emergency and Critical Care Medicine
Address	3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL	045-628-6100
Email	takei.icu@yokohama.jrc.or.jp

Public contact
Name of contact person	Junji HATAKEYAMA
Organization	Yokohama City Minato Red Cross Hospital
Division name	Department of Emergency and Critical Care Medicine
Address	3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL	045-628-6100
Homepage URL
Email	hatajun1228@yahoo.co.jp

Sponsor
Institute	Yokohama City Minato Red Cross Hospital
Institute
Department

Funding Source
Organization	Society for Yokohama Emergency Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
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	2013 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 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	None

Management information
Registered date	2013 Year 09 Month 10 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013683