UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024448 |
|---|---|
| Receipt number | R000028135 |
| Scientific Title | Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest |
| Date of disclosure of the study information | 2016/10/27 |
| Last modified on | 2017/10/19 15:29:03 |
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Basic information
Public title
Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Acronym
Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Scientific Title
Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Scientific Title:Acronym
Recovery Time of Motor Evoked Potentials in Rewarming Phase After Deep Hypothermic Circulatory Arrest
Region
| Japan |
Condition
Condition
Descending aortic aneurysm, Thoracoabdominal aortic aneurysm
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Paraplegia is a serious potential complication of descending aortic replacement(DAR) and thoracoabdominal aortic replacement(TAAR). DHCA has been applied in DAR and TAAR due to low risk of paraplegia. Normally MEP disappear in DHCA, but MEP have been used to confirm whether motor function is intact after DHCA. It's crucial to know the timing and the body temperature at MEP recovery in the rewarming phase. Therefore we will investigate the recovery time and the body temperature of MEP reappearance.
Basic objectives2
Others
Basic objectives -Others
We will examine which factors have an association with the recovery time of MEP.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recovery time of MEP
Key secondary outcomes
the body temperature at MEP recovery
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
Patients who underwent DAR and TAAR with DHCA between January 2013 and December 2015
Key exclusion criteria
Lack of MEP data,
Non lower extremity circulatory arrest,
Intraoperative death
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Yoshitani |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
06-6833-5012
sohtamikaze@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiki Kanemaru |
Organization
National Cerebral and Cardiovascular Center
Division name
Department of Anesthesiology
Zip code
Address
5-7-1 Fujishirodai, Suita, Osaka
TEL
06-6833-5012
Homepage URL
eiki-k.16@hotmail.co.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We extracted the data, recover time of MEP, the bladder and nasopharyngeal temperature when MEP recovered, the lower extremity circulatory arrest time, the rewarming time, and the lowest hemoglobin concentration.
Management information
Registered date
| 2016 | Year | 10 | Month | 17 | Day |
Last modified on
| 2017 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028135
