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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038458
Receipt No. R000043825
Scientific Title A study evaluating correlation of autonomic nervous system and outcome in septic patient
Date of disclosure of the study information 2019/11/04
Last modified on 2019/11/01

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Basic information
Public title A study evaluating correlation of autonomic nervous system and outcome in septic patient
Acronym A study evaluating correlation of autonomic nervous system and outcome in septic patient
Scientific Title A study evaluating correlation of autonomic nervous system and outcome in septic patient
Scientific Title:Acronym A study evaluating correlation of autonomic nervous system and outcome in septic patient
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Emergency medicine Intensive care medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of correlation between parameters of heart rate viability and outcomes of mortality, physical function and cognitive function
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Length of stay (ICU, HCU, hospital)
Key secondary outcomes Risk of ICU-AW
Risk of ICU-AD
Score of HDS-R at 28-day
Score of Barthel index at 28-day

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted to ICU or HCU via ED
Key exclusion criteria Patients infused catecholamine at arrival
Patients with nonsinus rhythm
Patients suffered cardiac transplantation
Patients suffered cardiac arrest before
Pregnant woman
Incapable of being attached electrode to chest
Patient withheld administration of cardiovascular agent
Attending physician's decision
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Ryuta
Middle name
Last name Nakashima
Organization Oita city medical association's Almeida memorial hospital
Division name Department of Emergency and Critical care medicine
Zip code 8701195
Address 1509-2 Miyazaki, Oita-city, Oita, Japan
TEL 097-569-3121
Email maruaal@almeida.oita.med.or.jp

Public contact
Name of contact person
1st name Ryuta
Middle name
Last name Nakashima
Organization Oita city medical association's Almeida memorial hospital
Division name Department of Emergency and Critical care medicine
Zip code 8701195
Address 1509-2 Miyazaki, Oita-city, Oita, Japan
TEL 097-569-3121
Homepage URL
Email maruaal@almeida.oita.med.or.jp

Sponsor
Institute Oita city medical association's Almeida memorial hospital
Department of Emergency and Critical care medicine
Institute
Department

Funding Source
Organization Kumamoto University
Graduate school of Medical Sciences
Division of Emergency and General 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 Oita city medical association's Almeida memorial hospital
Address 1509-2 Miyazaki, Oita-city, Oita, Japan
Tel 097-569-3121
Email maruaal@almeida.oita.med.or.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 11 Month 04 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 28 Day
Date of IRB
2019 Year 10 Month 30 Day
Anticipated trial start date
2019 Year 11 Month 04 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients are included in this study with s SOFA > 2. Heart rate viability are measured at day1, 2, 3, 4, 5, 7, 14 and 21.

Management information
Registered date
2019 Year 11 Month 01 Day
Last modified on
2019 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043825

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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