UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007802 |
|---|---|
| Receipt number | R000009191 |
| Scientific Title | Evaluation of the therapeutic effect of intravenous flurbiprofen axetil against mesenteric traction syndrome by continuous measurement of systemic vascular resistance index using a FloTrac sensor. |
| Date of disclosure of the study information | 2012/04/23 |
| Last modified on | 2012/04/20 18:41:52 |
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Basic information
Public title
Evaluation of the therapeutic effect of intravenous flurbiprofen axetil against mesenteric traction syndrome by continuous measurement of systemic vascular resistance index using a FloTrac sensor.
Acronym
Evaluation of the therapeutic effect of flurbiprofen against MTS.
Scientific Title
Evaluation of the therapeutic effect of intravenous flurbiprofen axetil against mesenteric traction syndrome by continuous measurement of systemic vascular resistance index using a FloTrac sensor.
Scientific Title:Acronym
Evaluation of the therapeutic effect of flurbiprofen against MTS.
Region
| Japan |
Condition
Condition
patients scheduled for elective open abdominal surgery
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measuring the systemic vascular resistance index continuously using a FloTrac sensor to get an objective evidence of MTS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
If flurbiprofen can treat the instability due to mesenteric traction syndrome (MTS), the systemic vascular resistance which is decreased by MTS, will recover quickly.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In flurbiprofen administration group, 50mg of flurbiprofen is injected intravenously after the onset of MTS, and we observe the hemodynamic changes.
Interventions/Control_2
In control group, patients receive no injections at those times, and we observe the hemodynamic changes.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients (American Society of Anaesthesiologists physical status [ASA-PS] 1-2 ) scheduled for elective open abdominal surgery
Key exclusion criteria
Patient who is taking any steroidal or non-steroidal anti-inflammatory drug (NSAID) that might influence COX activities.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoshi Takada |
Organization
Daiyukai General Hospital
Division name
Dep of Anesthesia
Zip code
Address
1-9-9 Sakura, Ichinomiya, Aichi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Daiyukai General Hospital
Division name
Dep of Anesthesia
Zip code
Address
TEL
Homepage URL
masui@daiyukai.or.jp
Sponsor or person
Institute
Daiyukai General Hospital
Dep of Anesthesia
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009191
