UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007602 |
|---|---|
| Receipt number | R000008982 |
| Scientific Title | The study of change of electrolyte in patients with sbuarachnoid hemorrhage |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2013/04/05 13:03:35 |
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Basic information
Public title
The study of change of electrolyte in patients with sbuarachnoid hemorrhage
Acronym
The change of electrolyte in patients with SAH
Scientific Title
The study of change of electrolyte in patients with sbuarachnoid hemorrhage
Scientific Title:Acronym
The change of electrolyte in patients with SAH
Region
| Japan |
Condition
Condition
subarachnoid hemorrhage
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the change of serum levels of sodium and potassium ion
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the presence or absence of hypokalemia
Key secondary outcomes
the presence of hypernatremia
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 study inclusion criteria were age 18 years or older, measurements of serum electrolyte levels and physical examinations performed at the emergency department, and aSAH diagnosed on the basis of admission computed tomography (CT) or xanthochromia of the cerebral fluid.
Key exclusion criteria
patients with cardiopulmonary arrest, renal failure (serum levels of creatinine > 2.0 mg/dL), blood test with hemolysis, and medication of insulin, digitalis, quinidine, glycyrrhizin, or diuretics.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOSINOBU KIMURA |
Organization
Asahikawa Redcross Hospital
Division name
Anesthesia
Zip code
Address
1-1-1-1 Akebono, Asahikawa, Hokkaido, Japan
TEL
0166228111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kimura |
Organization
anesthesia
Division name
anesthesia
Zip code
Address
1-1-1-1 Akebono, Asahikawa, Hokkaido, Japan
TEL
0166228111
Homepage URL
Sponsor or person
Institute
anesthesia
Institute
Department
Personal name
Funding Source
Organization
NONE
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
旭川赤十字病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2012 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008982
