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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003863
Receipt No. R000004649
Scientific Title Usefulness of pleth variability index to predict fluid responsiveness in patients undergoing Cesarean section
Date of disclosure of the study information 2010/07/15
Last modified on 2010/07/03

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Basic information
Public title Usefulness of pleth variability index to predict fluid responsiveness in patients undergoing Cesarean section
Acronym Usefulness of pleth variability index during Cesarean section
Scientific Title Usefulness of pleth variability index to predict fluid responsiveness in patients undergoing Cesarean section
Scientific Title:Acronym Usefulness of pleth variability index during Cesarean section
Region
Japan

Condition
Condition Usefulness of pleth variability index to predict fluid responsiveness in patients undergoing Cesarean section
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Usefulness of pleth variability index to predict fluid responsiveness in patients undergoing Cesarean section
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Apgar Score
Key secondary outcomes pleth variability index

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Measurement of pleth variability index
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
18 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria 1)spinal anesthesia
2)ASA(American Society of Anesthesiology) 1
3)elective cesarean section
Key exclusion criteria 1)body mass index 35 > kg&#8226;m-2
2)nonresssuring fetal status
3)hypotenssion
4)pleth variability index < 7
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokuhiro Yamada
Organization Osaka City University Graduate School of Medicine, Osaka, Japan
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahimachi, Abeno-ku, Osaka 545-8586, Japan
TEL 81-6-6645-2186
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tokuhiro Yamada
Organization Department of Anesthesiology
Division name Department of Anesthesiology
Zip code
Address
TEL 81-6-6645-2186
Homepage URL
Email

Sponsor
Institute Osaka City University Hospital (Osaka, Japan)
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2010 Year 07 Month 15 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 Open public recruiting
Date of protocol fixation
2009 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 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
2010 Year 07 Month 03 Day
Last modified on
2010 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004649

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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