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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016890
Receipt No. R000019586
Scientific Title Perioperative fluid management affect extra lung water index and global end diastolic index.
Date of disclosure of the study information 2015/03/24
Last modified on 2018/09/25

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Basic information
Public title Perioperative fluid management affect extra lung water index and global end diastolic index.
Acronym Perioperative hemodynamic change compared albumin to crystalloid.
Scientific Title Perioperative fluid management affect extra lung water index and global end diastolic index.
Scientific Title:Acronym 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
1st name
Middle name
Last name shunsuke takaki
Organization Yokohama City University University
Division name Intensive Care Unit
Zip code
Address 3-9 Fukuura Kanazawaku Yokohama
TEL 045-787-2800
Email shunty5323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name shunsuke takaki
Organization Yokohama City University University
Division name Intensive Care Unit
Zip code
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)

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
2015 Year 03 Month 24 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 Completed
Date of protocol fixation
2015 Year 03 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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