UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034301
Receipt No. 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 2018/09/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Keiichiro Mizuno
Organization Fukuoka Children's Hospital
Division name Department of Anesthesia
Zip code
Address 5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL 092-682-7000
Email umin-ctr@dafch.org

Public contact
Name of contact person
1st name
Middle name
Last name Keiichiro Mizuno
Organization Fukuoka Children's Hospital
Division name Department of Anesthesia
Zip code
Address 5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
TEL 092-682-7000
Homepage URL
Email umin-ctr@dafch.org

Sponsor
Institute Fukuoka Children's Hospital
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 27 Day
Last follow-up date
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
2018 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039103

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.