UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008805 |
|---|---|
| Receipt number | R000010341 |
| Scientific Title | Changes of serum ionized magnesium during surgery |
| Date of disclosure of the study information | 2012/08/31 |
| Last modified on | 2014/06/06 17:11:39 |
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Basic information
Public title
Changes of serum ionized magnesium during surgery
Acronym
Ionized magnesium during surgery
Scientific Title
Changes of serum ionized magnesium during surgery
Scientific Title:Acronym
Ionized magnesium during surgery
Region
| Japan |
Condition
Condition
Surgical patients
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the changes of serum ionized magenesium during long surgery and also relationship between hypomagnesium and incidence of postoperative complication, such as shivering or arrythemia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
serum ionized magnesium
Key secondary outcomes
incidence of postoperative shivering and arrythemia
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Ptient who need arterial cannulation during surgery
Key exclusion criteria
Patient who refuse this study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tateda Takeshi |
Organization
St. Marianna University School of Medicine
Division name
Anesthesiology
Zip code
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
t2tateda@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tateda Takeshi |
Organization
St. Marianna University School of Medicine
Division name
Anesthesiology
Zip code
Address
2-16-1, Sugao, Miyamae, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
t2tateda@marianna-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
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
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
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Our result showed that serum inonaized Mg decresed during surgery over 6hrs.
In step wise regeression analysis, decrese of ionized Mg corelated with amount of blood loss during surgery
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 | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 30 | Day |
Other
Other related information
we mesure ionized magnesium at beginning and end of surgery.
We also analyze incidence of postoperative shivering and arrythemia.
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2014 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010341
