UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001687 |
|---|---|
| Receipt number | R000002037 |
| Scientific Title | A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery |
| Date of disclosure of the study information | 2009/02/05 |
| Last modified on | 2009/02/05 17:29:48 |
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Basic information
Public title
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Acronym
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Scientific Title
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Scientific Title:Acronym
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Region
| Japan |
Condition
Condition
coronary artery bypass patients
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the feasibility of treatment with Sivelestat in patients undergoing cardiac surgery with the aid of cardiopulmonary bypass.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Completeness of the study in enrolled patients.
Peri-operative morbidity
Key secondary outcomes
Clinical outcomes such as lenghts of hospital stay.
Pulmonary function
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
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous intravenous administration of the neutrophil erastase inhibitor
Interventions/Control_2
Continuous intravenous administration of isotonic sodium chloride solution
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
Patients scheduled for elective, isolated on-pump coronary artery bypass
Key exclusion criteria
Patients requiring either preoperative intravenous inotropic or vasodilative drugs, intraaortic balloon support, supplemental oxygen, or mechanical ventilation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ueda |
Organization
Nagoya University Hospital
Division name
Department of Cardiac Surgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2376
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University Hospital
Division name
Department of Cardiac Surgery
Zip code
Address
TEL
052-744-2376
Homepage URL
Sponsor or person
Institute
Nagoya University Hospital
Department of Cardiac Surgery
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Hospital
Department of Cardiac Surgery
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
| 2009 | Year | 02 | Month | 05 | 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
| 2004 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 05 | Day |
Last modified on
| 2009 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002037
