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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001687
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Nagoya University Hospital
Department of Cardiac Surgery
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002037

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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