UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003863 |
|---|---|
| Receipt number | 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 10:44:50 |
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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•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
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
Sponsor or person
Institute
Osaka City University Hospital (Osaka, Japan)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004649
