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 | 2026/02/01 17:42:19 |
* 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
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
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
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
43
Results
The primary outcome was vasopressor-free days, which were 7.0 +/- 5.0 days in the clinically-guided duration group and 8.1 +/- 3.9 days in the fixed duration group, with a mean difference of -1.0 (95% confidence interval: -3.8, 1.8), demonstrating non-inferiority (P value for non-inferiority: <0.001).
Results date posted
| 2026 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Inclusion criteria required patients to be receiving norepinephrine at >=0.2 ug/kg/min (base equivalent dose), or a combination of epinephrine and vasopressin, along with hydrocortisone at a dose of 250 mg/day. Patients in whom sepsis had been diagnosed and corticosteroid therapy initiated within 48 h before enrollment were included.
Exclusion criteria were as follows: patients with chronic corticosteroid use, those with indication of corticosteroid for something other than septic shock, those with underlying diseases with a life expectancy <3 months, those with limitations on life-sustaining treatments, those in whom death was expected within 48 h, and those for whom the attending physicians otherwise decided that study inclusion was inappropriate.
Participant flow
Out of 143 screened patients, 43 were enrolled, 23 of whom were randomized to the clinically-guided duration group and 20 to the fixed duration group .
Adverse events
Regarding adverse events, the rate of new infections or worsening of the treated infection that required antibiotic administration within 28 days was significantly higher in the fixed duration group than in the group with the clinically-guided duration (55% vs 22%, p=0.031). There was no difference between the groups regarding other adverse events including hyperglycemia requiring insulin and hypernatremia, and there was no significant difference in terms of in-hospital mortality.
Outcome measures
The primary outcome was the number of vasopressor-free days. This was defined as the number of days alive within 14 days after the randomization without the use of norepinephrine. In cases where the patient died within 14 days, the number of vasopressor-free days was set at 0.
The secondary outcomes included the duration of hydrocortisone administration, the time to shock resolution, the recurrence of shock, the number of ventilator-free days and the number of ICU-free days. The duration of hydrocortisone administration was defined as the period from the initiation to the discontinuation of hydrocortisone therapy specifically for septic shock replacement therapy. Shock resolution was defined as discontinuation of norepinephrine without the decreased mean arterial pressure below the target for 24 h. Shock recurrence was defined as the hypotension requiring the initiation or increase of norepinephrine dose by >0.1 ug/kg/min within 24 h after the discontinuation or tapering of hydrocortisone. "Ventilator-free days" was defined as the number of days within the 14-day period after the randomization during which the patient was not receiving mechanical ventilation. This definition included days without either invasive or noninvasive positive pressure ventilation. "ICU-free days" was defined as the number of days out of a 14-day period, starting from the day of randomization, during which the patient stayed alive outside of the ICU.
Additionally, we evaluated adverse events that might be related to hydrocortisone administration. After randomization, the following adverse events were evaluated: hyperglycemia requiring insulin therapy, hypernatremia (>=150 mEq/L serum sodium concentration), clinically significant peptic ulcers requiring intervention (e.g., transfusion and upper gastroduodenoscopy) occurring during 14 days, worsening infections or new infections requiring the re-administration or escalation of antimicrobial therapy, and myositis (248 IU/L [upper limit of our institutions] or higher serum creatine kinase).
Plan to share IPD
There is no plan to share the individual participant data.
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047638
