UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of perioperative Goal Directed Therapy for free-flap surgery
Title of the study (Brief title)	Prospective study of GDT for free-flap surgery
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology Anesthesiology Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate prospectively whether infusion and vasopressors management by GDT protocol during and after surgery can reduce the length of hospital stay and the number of postoperative complications as compared to the management that do not use the protocol
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Complications during 28 days after surgery
Key secondary outcomes	Length of hospital stay

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	General monitor, arterial line (frotrac sensor and vigileo monitor) and CV line are used Fluid administration and vasoactive agents using GDT protocol
Interventions/Control_2	General monitor, arterial line and CV line are used Liberal fluid administration and vasoactive agents upon an anesthesiologist judgement
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) ASA 1or2 2) Written informed concent must be obtaind from patients
Key exclusion criteria	1) ASA >3 2) Emergency surgery 3) Patients enrollment to the study is determinated to be inappropriate
Target sample size	80

Research contact person
Name of lead principal investigator	Ichiro Kondo
Organization	Jikei University School of Medicine
Division name	Department of Anesthesiology
Address	3-25-8Nishishinbashi Minatoa-ku Tokyo
TEL	0334331111
Email	ichirok@jikei.ac.jp

Public contact
Name of contact person	Ichiro Kondo
Organization	Jikei University Hospital
Division name	Department of Anesthesiology
Address	3-19-18 Nishishinbashi Minatoa-ku Tokyo
TEL	0334331111
Homepage URL
Email	ichirok@jikei.ac.jp

Sponsor
Institute	Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Edwards Life Science
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2015 Year 05 Month 26 Day
Last follow-up date
Date of closure to data entry	2018 Year 07 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 08 Day
Last modified on	2019 Year 01 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019477