UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026957 |
|---|---|
| Receipt number | R000030916 |
| Scientific Title | The effects of perfusion index-guided hemodynamic management (A randomized trial) |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2019/11/13 12:38:37 |
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Basic information
Public title
The effects of perfusion index-guided hemodynamic management (A randomized trial)
Acronym
The effects of perfusion index-guided hemodynamic management
Scientific Title
The effects of perfusion index-guided hemodynamic management (A randomized trial)
Scientific Title:Acronym
The effects of perfusion index-guided hemodynamic management
Region
| Japan |
Condition
Condition
Adult patients undergoing elective surgery
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of perfusion index-guided hemodynamic management in patients undergoing surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative lactate levels
Key secondary outcomes
Intraoperative hypotension rate, intraoperative fluid volume, intraoperative urine output, and postoperative complication rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perfusion index-guided intraoperative hemodynamic management
Interventions/Control_2
Usual intraoperative hemodynamic management
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
Adult patients undergoing elective surgery with arterial line
Key exclusion criteria
History of uncompensated cardiac disease, stroke, arrhythmias, and severe liver/renal dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Kagoshima University Hospital
Division name
Department of Anesthesiology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
0992755430
kouhei84@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Godai |
Organization
Kagoshima University Hospital
Division name
Department of Anesthesiology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
0992755430
Homepage URL
kouhei84@hotmail.co.jp
Sponsor or person
Institute
Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee on Clinical Studies, Kagoshima University Hospital
Address
Kagoshima
Tel
0992756692
kufsyomu@kuas.kagoshima-u.ac.jp
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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jaclinicalreports.springeropen.com/articles/10.1186/s40981-019-0291-5
Number of participants that the trial has enrolled
40
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
| 2017 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 09 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2019 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030916
