UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011702 |
|---|---|
| Receipt number | R000013683 |
| Scientific Title | NEuromuscular pathology in CRitically ill patients: an autOPSY Study "NECROPSY Study" |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2017/01/05 10:24:11 |
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Basic information
Public title
NEuromuscular pathology in CRitically ill patients: an autOPSY Study "NECROPSY Study"
Acronym
NECROPSY Study
Scientific Title
NEuromuscular pathology in CRitically ill patients: an autOPSY Study "NECROPSY Study"
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tetsuhiro TAKEI |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL
045-628-6100
takei.icu@yokohama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji HATAKEYAMA |
Organization
Yokohama City Minato Red Cross Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
3-12-1 Shin-yamashita, Naka-ku, Yokohama, 231-8682, Japan
TEL
045-628-6100
Homepage URL
hatajun1228@yahoo.co.jp
Sponsor or person
Institute
Yokohama City Minato Red Cross Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013683
