UMIN-CTR Clinical Trial

Basic information
Public title	Trial for the safety of early discontinuation of low-dose steroids in patients with septic shock
Acronym	Trial for the safety of early discontinuation of low-dose steroids in patients with septic shock
Scientific Title	A retrospective randomized controlled trial of early withdrawal of low dose steroid in patients with septic shock
Scientific Title:Acronym	A retrospective randomized controlled trial of early withdrawal of low dose steroid in patients with septic shock
Region	Japan

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

Objectives
Narrative objectives1	To clarify that the use of the protocol can shorten the administration period without adverse events in steroid replacement therapy for patients with septic shock.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Number of days in 14 days that no vasopressor was used
Key secondary outcomes	Duration of steroid administration

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Inteventions : The initial therapeutic dose is 250 mg of hydrocortisone. When norepinephrine can be reduced to less than 0.2 gamma hydrocortisone will be reduced to 100mg and discontinued the next day.
Interventions/Control_2	Contorol :The initial therapeutic dose is 250 mg of hydrocortisone. hydrocortisone is continued for 7 days or until ICU is discharged and then discontinued.
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	Patients over the age of 20 who have been diagnosed with septic shock and require norepinephrine 0.2 gamma or higher to maintain blood pressure and require steroid replacement therapy
Key exclusion criteria	Patients with administration of steroids for other diseases limited treatment required for life support, and prognosis within 3 months of prognosis
Target sample size	56

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Nakashima
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-441-0603
Email	nakanaka@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Tsuyoshi Middle name Last name Nakashima
Organization	Wakayama Medical University
Division name	Department of Emergency and Critical Care Medicine
Zip code	641-8510
Address	811-1, Kimiidera, Wakayama City, Wakayama, Japan
TEL	073-441-0603
Homepage URL
Email	nakanaka@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	self funding
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	Wakayama Medical University
Address	811-1, Kimiidera, Wakayama City, Wakayama, Japan
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.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	2020 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	Open public recruiting
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 10 Month 10 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2025 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 09 Day
Last modified on	2021 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047638

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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