UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041734
Receipt No. R000047638
Scientific Title A retrospective randomized controlled trial of early withdrawal of low dose steroid in patients with septic shock
Date of disclosure of the study information 2020/10/01
Last modified on 2021/03/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.