UMIN-CTR Clinical Trial

Basic information
Public title	VAsopressin LOading for Refractory septic shock VALOR study
Acronym	VALOR study
Scientific Title	VAsopressin LOading for Refractory septic shock VALOR study
Scientific Title:Acronym	VALOR study
Region	Japan

Condition
Condition	septic shock
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the response, meaning and safety of vasopressin loading for patients with septic shock
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The catecholamine index change six hours after the initiation of continuous vasopressin administration
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.age>=18 2.septic shock (Sepsis-3) 3.require vasopressin administration in the patients given continuous noradrenaline>=0.2gamma 4.not given continuous steroid therapy 5.arterial line inserted 6.informed consent
Key exclusion criteria	End of life/Terminal care
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Nakamura
Organization	Hitachi General Hospital
Division name	Emergency and Critical Care Medicine
Zip code	116-0003
Address	2-1-1 Jonancho Hitachi Ibaraki Japan
TEL	0294-23-1111
Email	mamashockpapashock@yahoo.co.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Nakamura
Organization	Hitachi General Hospital
Division name	Emergency and Critical Care Medicine
Zip code	116-0003
Address	2-1-1 Jonancho Hitachi Ibaraki Japan
TEL	0294-23-1111
Homepage URL
Email	mamashockpapashock@yahoo.co.jp

Sponsor
Institute	Hitachi General Hospital
Institute
Department

Funding Source
Organization	Hitachi General Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hitachi General Hospital
Address	Emergency and Critical Care Medicine
Tel	0294-23-1111
Email	masahiro.miura.cz@hitachi.com

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	2021 Year 04 Month 26 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	Open public recruiting
Date of protocol fixation	2021 Year 01 Month 19 Day
Date of IRB	2021 Year 02 Month 15 Day
Anticipated trial start date	2021 Year 04 Month 26 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Dividing responder/non-responder with the response to vasopressin loading in the patients with septic shock who require vasopressin infusion, we evaluate endocrine background, circulation status and clinical outcomes.

Management information
Registered date	2021 Year 04 Month 26 Day
Last modified on	2021 Year 10 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050288