UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044041 |
|---|---|
| Receipt number | R000050288 |
| Scientific Title | VAsopressin LOading for Refractory septic shock VALOR study |
| Date of disclosure of the study information | 2021/04/26 |
| Last modified on | 2021/10/26 16:23:16 |
* 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
VAsopressin LOading for Refractory septic shock VALOR study
Acronym
VALOR study
Scientific Title
VAsopressin LOading for Refractory septic shock VALOR study
Scientific Title:Acronym
VALOR study
Region
| Japan |
Condition
Condition
septic shock
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the response, meaning and safety of vasopressin loading for patients with septic shock
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The catecholamine index change six hours after the initiation of continuous vasopressin administration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.age>=18
2.septic shock (Sepsis-3)
3.require vasopressin administration in the patients given continuous noradrenaline>=0.2gamma
4.not given continuous steroid therapy
5.arterial line inserted
6.informed consent
Key exclusion criteria
End of life/Terminal care
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
116-0003
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
0294-23-1111
mamashockpapashock@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Hitachi General Hospital
Division name
Emergency and Critical Care Medicine
Zip code
116-0003
Address
2-1-1 Jonancho Hitachi Ibaraki Japan
TEL
0294-23-1111
Homepage URL
mamashockpapashock@yahoo.co.jp
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi General Hospital
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
Hitachi General Hospital
Address
Emergency and Critical Care Medicine
Tel
0294-23-1111
masahiro.miura.cz@hitachi.com
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
| 2021 | Year | 04 | Month | 26 | 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
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Dividing responder/non-responder with the response to vasopressin loading in the patients with septic shock who require vasopressin infusion, we evaluate endocrine background, circulation status and clinical outcomes.
Management information
Registered date
| 2021 | Year | 04 | Month | 26 | Day |
Last modified on
| 2021 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050288
