UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Perioperative fluid management affect extra lung water index and global end diastolic index.
Title of the study (Brief title)	Perioperative hemodynamic change compared albumin to crystalloid.
Region	Japan

Condition
Condition	Patients who performed resection of laryngopharynx tumor and reconstruction by flap
Classification by specialty	Oto-rhino-laryngology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Assessment hemodynamic change after fluid challenge at the timing of inflammatory response.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is to assess extra lung water index and global end diastolic index after administration of fluid challenge, and compare those change by different fluid.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration crystalloid followed by albumin
Interventions/Control_2	Administration albumin followed by crystalloid
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who performed resection of laryngophyrynx tumor and reconstruction by flap will be included.
Key exclusion criteria	Patients who age under 18 years old and sever pulmonary complication will be excluded.
Target sample size	25

Research contact person
Name of lead principal investigator	shunsuke takaki
Organization	Yokohama City University University
Division name	Intensive Care Unit
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2800
Email	shunty5323@gmail.com

Public contact
Name of contact person	shunsuke takaki
Organization	Yokohama City University University
Division name	Intensive Care Unit
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2800
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Yokohama City University Department of Anesthesiology
Organization
Division
Category of Funding Organization	Self funding
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 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 18 Day
Anticipated trial start date	2015 Year 03 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
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 03 Month 24 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019586