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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026957
Receipt No. 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 2019/04/30

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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
Obsterics 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
Email 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
Email kouhei84@hotmail.co.jp

Sponsor
Institute Kagoshima University Hospital
Institute
Department

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
Email 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 Unpublished

Result
URL related to results and publications
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 No longer recruiting
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 12 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030916

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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