UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016816 |
|---|---|
| Receipt number | R000019525 |
| Scientific Title | Neurological prognostic value of adjusted Ca2+ concentration in patients with out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2015/03/17 14:28:51 |
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Basic information
Public title
Neurological prognostic value of adjusted Ca2+ concentration in patients with out-of-hospital cardiac arrest
Acronym
Neurological prognostic value of adjusted Ca2+ concentration in patients with out-of-hospital cardiac arrest
Scientific Title
Neurological prognostic value of adjusted Ca2+ concentration in patients with out-of-hospital cardiac arrest
Scientific Title:Acronym
Neurological prognostic value of adjusted Ca2+ concentration in patients with out-of-hospital cardiac arrest
Region
| Japan |
Condition
Condition
Post-resuscitation encephalopathy
Classification by specialty
| Cardiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship of serum Ca2+ concentration and other factors related with Ca metabolism (Vitamin D(1,25(OH)2D,25OHD), parathyroid hormone (intact PTH),P,Mg etc) in acute phase with neurological prognosis after ROSC.
Basic objectives2
Others
Basic objectives -Others
To clarify the predictive factor by observational assessment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between serum ionized-calcium concentration, other factors related with calcium metabolism and Cerebral performance category(CPC) after ROSC
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
The patients with return of spontaneous circulation (ROSC) from out-of-hospital cardiac arrest
Key exclusion criteria
anemia(Hb <9g/dL)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Akasaka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Molecular Medicine and Therapeutics
Zip code
Address
86 Nishi-cho,Yonago-shi,Tottori-ken
TEL
0859-38-6517
t.akasaka@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Akasaka |
Organization
Tottori University Faculty of Medicine
Division name
Division of Molecular Medicine and Therapeutics
Zip code
Address
86 Nishi-cho,Yonago-shi,Tottori-ken
TEL
0859-38-6517
Homepage URL
t.akasaka@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Tottori university faculty of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the relationship of serum Ca2+ concentration and other factors related with Ca metabolism (Vitamin D(1,25(OH)2D,25OHD), parathyroid hormone (intact PTH),P,Mg etc) in acute phase with neurological prognosis after ROSC.
Management information
Registered date
| 2015 | Year | 03 | Month | 17 | Day |
Last modified on
| 2015 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019525
