UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025051 |
|---|---|
| Receipt number | R000028827 |
| Scientific Title | Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation |
| Date of disclosure of the study information | 2016/11/29 |
| Last modified on | 2017/05/07 20:32:45 |
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Basic information
Public title
Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Acronym
Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Scientific Title
Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Scientific Title:Acronym
Examination of the effect of dexmedetomidine on reperfusion injury due to isolated pulmonary ventilation
Region
| Japan |
Condition
Condition
reperfusion injury
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In isolated lung ventilation, it is known that the non-ventilatory side blood flow decreases and the cytokine associated with reperfusion injury increases after restarting bilateral ventilation. Disorders of the lung are the most frequent complications after the operation of the isolated lung ventilation, and anesthesia management that prevents pulmonary complications is necessary. On the other hand, dexmedetomidine has been reported to have anti-inflammatory and antioxidative effects, and it has been reported that reperfusion injury due to artificial heart-lung and liver prying technique and suppression of elevation of inflammatory cytokines can be suppressed. However, the effect of dexmedetomidine on reperfusion injury associated with isolated lung ventilation is unknown. If dexmedetomidine has an action of suppressing reperfusion injury due to isolated pulmonary ventilation, it can contribute to prevention of pulmonary complications in isolated lung ventilation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Inflammatory cytokines in serum
Key secondary outcomes
Vital, blood gas analysis, postoperative pain, resected lung weight, general blood sampling before and after surgery, extent of postoperative sedation, amount of urine, postoperative complications, days of stay in ICU, days to stay in hospital etc
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine administered group
Interventions/Control_2
Control/Saline group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo lung resection with isolated lung ventilation and enter ICU after surgery
Key exclusion criteria
Allergic to Dexmedetomidine
lung and systemic inflammatory diseases
BMI 35 over
reoperative patients
patients with impaired cardiac function
Hugh Jones classification 4 or more
autoimmune disease
immunosuppressive agent administration
Patients who are not indicated for extramembrane anesthesia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Amane Konishi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Anesthesia and Perioperative Medicine
Zip code
Address
Ehime Prefecture Toon City Shitsukawa
TEL
089-960-5383
konishi.amane.cs@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Amane Konishi |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Anesthesia and Perioperative Medicine
Zip code
Address
Ehime Prefecture Toon City Shitsukawa
TEL
089-960-5383
Homepage URL
konishi.amane.cs@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Department of Anesthesia and Perioperative Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
愛媛大学医学部付属病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 29 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2017 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028827
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
