UMIN-CTR Clinical Trial

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
Email	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
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	IRB, Fukuoka Children's Hospital
Address	5-1-1 Kashiiteriha, Higashi-ku, Fukuoka 813-0017, JAPAN
Tel	092-682-7000
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039103