UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011024 |
|---|---|
| Receipt number | 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 13:40:02 |
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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
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
ttatara@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012904
