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UMIN-CTR Clinical Trial |
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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 | 2020/11/05 |
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 |
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Condition | ||
Condition | Septic shock | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Inteventions : The initial therapeutic dose is 200 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 200 mg of hydrocortisone. hydrocortisone is continued for 7 days or until ICU is discharged and then discontinued. | |
Interventions/Control_3 | ||
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Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
nakanaka@wakayama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |