UMIN-CTR Clinical Trial

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