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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000650
Receipt No. 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

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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)
Email

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
Email obara@sc.itc.keio.ac.jp

Sponsor
Institute Keio University, School of Medicine
Department of Surgery
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000784

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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