UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038458 |
|---|---|
| Receipt number | 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 | 2021/04/07 21:33:02 |
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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, serum catecholamine concentration 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
Infusion dose of cardiovascular agent
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
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
maruaal@almeida.oita.med.or.jp
Sponsor or person
Institute
Oita city medical association's Almeida memorial hospital
Department of Emergency and Critical care medicine
Institute
Department
Personal name
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
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
69
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 | 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
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Patients are included in this study with q-SOFA score > 2 on first vital sign at ER. Heart rate viability are measured at day1, 2, 3, 4, 5, 7 and 14.
Management information
Registered date
| 2019 | Year | 11 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043825
