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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011024
Receipt No. R000012904
Scientific Title Effect of continuous administration of vasoconstrictors on fluid accumulation during surgery
Date of disclosure of the study information 2013/10/01
Last modified on 2016/12/26

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Basic information
Public title Effect of continuous administration of vasoconstrictors on fluid accumulation during surgery
Acronym Vasoconstrictors and fluid accumulation
Scientific Title Effect of continuous administration of vasoconstrictors on fluid accumulation during surgery
Scientific Title:Acronym Vasoconstrictors and fluid accumulation
Region
Japan

Condition
Condition Abdominal surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether continuous administration of vasoconstrictors decreases fluid volume and reduces fluid accumulation during abdominal surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Total fluid volume, bioelectrical impedance
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group C: no administration of vasoconstrictor (control)
Interventions/Control_2 Group P: continuous intravenous administration of phenylephrine
Interventions/Control_3 Group N: continuous intravenous administration of noradrenaline
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
79 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective open abdominal surgery
Key exclusion criteria Severe cardiac, pulmonary or renal dysfunction
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Tatara
Organization Hyogo College of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6392
Email ttatara@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuneo Tatara
Organization Hyogo College of Medicine
Division name Department of Anesthesiology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6392
Homepage URL
Email ttatara@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
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
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 兵庫医科大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 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
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
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 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
2013 Year 06 Month 24 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012904

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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