UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016890 |
|---|---|
| Receipt number | 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 10:21:40 |
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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
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
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019586
