UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041734
Receipt number 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 12:29:24

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.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