UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034301 |
|---|---|
| Receipt number | R000039103 |
| Scientific Title | Plasma concentrations of catecholamines following adrenaline infiltration during Cranial Osteogenesis for the Treatment of Craniosynostosis |
| Date of disclosure of the study information | 2018/09/27 |
| Last modified on | 2020/05/23 14:46:02 |
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Basic information
Public title
Plasma concentrations of catecholamines following adrenaline infiltration during Cranial Osteogenesis for the Treatment of Craniosynostosis
Acronym
Plasma concentrations of catecholamines following adrenaline infiltration during Cranial Osteogenesis for the Treatment of Craniosynostosis
Scientific Title
Plasma concentrations of catecholamines following adrenaline infiltration during Cranial Osteogenesis for the Treatment of Craniosynostosis
Scientific Title:Acronym
Plasma concentrations of catecholamines following adrenaline infiltration during Cranial Osteogenesis for the Treatment of Craniosynostosis
Region
| Japan |
Condition
Condition
Craniosynostosis
Classification by specialty
| Anesthesiology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adrenaline is used for local infiltration during surgery to reduce bleeding and improve surgical vision. This study was designed to measure the changes in plasma adrenaline concentration and hemodynamics in response to local infiltration of adrenaline during cranial osteogenesis under general anaesthesia.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma concentrations of catecholamines
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
| 1 | months-old | <= |
Age-upper limit
| 120 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Children with craniosynostosis who are scheduled for cranial distraction osteogenesis surgery.
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiichiro |
| Middle name | |
| Last name | Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesia
Zip code
813-0017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL
092-682-7000
umin-ctr@dafch.org
Public contact
Name of contact person
| 1st name | Keiichiro |
| Middle name | |
| Last name | Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Department of Anesthesia
Zip code
813-0017
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL
092-682-7000
Homepage URL
umin-ctr@dafch.org
Sponsor or person
Institute
Fukuoka Children's Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Children's 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
IRB, Fukuoka Children's Hospital
Address
5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
Tel
092-682-7000
k-keiei@fcho.jp
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
| 2018 | Year | 09 | Month | 27 | 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
| 2018 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Arterial blood sample is obtained before, immediatly after local infiltration of 1:200,000 adrenaline, 30 minutes, 60 minutes, and 120 minutes thereafter. Blood samples are centrifuged immediately and the plasma separated and stored at -70 degrees Celsius for futurc analysis. Plasma concentrations of adrenaline, noradrenaline, and dopamine are measured with high pressure liquid chromatography.
Management information
Registered date
| 2018 | Year | 09 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
