UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000650 |
|---|---|
| Receipt number | R000000784 |
| Scientific Title | Efficacy of sivelestat sodium administration in perioperative care of abdominal aortic aneurysm with pulmonary function disorder |
| Date of disclosure of the study information | 2007/05/01 |
| Last modified on | 2011/04/15 00:21:20 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of sivelestat sodium administration in perioperative care of abdominal aortic aneurysm with pulmonary function disorder
Acronym
sivelestat sodium and abdominal aortic aneurysm
Scientific Title
Efficacy of sivelestat sodium administration in perioperative care of abdominal aortic aneurysm with pulmonary function disorder
Scientific Title:Acronym
sivelestat sodium and abdominal aortic aneurysm
Region
| Japan |
Condition
Condition
abdominal aortic aneurysm
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the efficacy of sivelestat sodium administration in perioperative care of abdominal aortic aneurysm with pulmonary function disorder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of postoperative complications, lung injury score, duration of SIRS
Key secondary outcomes
mortality rate, in-hospital days, period in ICU, mechanical ventilation period, each cytokines
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intervention group: 4.8mg/kg of sivelestat sodium is dissolved in 50ml of saline and is continuously injected intravenously for 24 hours. The continuous injection is started during
the operation and will be continued for at least 5 days (until 4 POD).
Interventions/Control_2
control group(placebo group): 50ml of saline is continuously injected intravenously for 24 hours. The continuous injection is started during the operation and will be continued for at least 5 days (until 4 POD).
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
The participants should be over 20 years old and should have written consent to participate in the trial.
Patients with the P/F ratio of less than 300mmHg and the chest X-ray showing bilateral infiltration shadow during the operation will be included in the trial, because at the moment, administration of sivelestat sodium is covered by the insurance only for patients with the acute lung injury.
Key exclusion criteria
Cases matching following conditions are excluded from the trial.
(1)Patients allergic to the components of sivelestat sodium.
(2)Patients who are pregnant, have a possibility of pregnancy, and breast-feeding.
(3)Patients with evidence of high left atrium pressure.
(4)Cases that are considered not eligible for the trial by the doctor in charge.
(5)Patients without pulmonary function disorder, meaning patients with the P/F ratio of more than 300 and the chest X-ray that does not show bilateral infiltration shadow during the operation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsumoto Kenji |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinjukuku Shinanomachi 35, Tokyo
TEL
03-3353-1211(62334)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Obara Hideaki |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinjukuku Shinanomachi 35, Tokyo
TEL
03-3353-1211(62334)
Homepage URL
obara@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University, School of Medicine
Department of Surgery
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
none
Name of secondary funder(s)
none
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
| 2007 | Year | 05 | 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
| 2007 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 23 | Day |
Last modified on
| 2011 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000784
