Unique ID issued by UMIN | UMIN000001687 |
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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 |
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Japan |
coronary artery bypass patients
Cardiovascular surgery |
Others
NO
To determine the feasibility of treatment with Sivelestat in patients undergoing cardiac surgery with the aid of cardiopulmonary bypass.
Safety,Efficacy
Completeness of the study in enrolled patients.
Peri-operative morbidity
Clinical outcomes such as lenghts of hospital stay.
Pulmonary function
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is considered as a block.
YES
Central registration
2
Treatment
Medicine |
Continuous intravenous administration of the neutrophil erastase inhibitor
Continuous intravenous administration of isotonic sodium chloride solution
20 | years-old | <= |
Not applicable |
Male and Female
Patients scheduled for elective, isolated on-pump coronary artery bypass
Patients requiring either preoperative intravenous inotropic or vasodilative drugs, intraaortic balloon support, supplemental oxygen, or mechanical ventilation
20
1st name | |
Middle name | |
Last name | Yuichi Ueda |
Nagoya University Hospital
Department of Cardiac Surgery
65 Tsurumai-cho, Showa-ku, Nagoya
052-744-2376
1st name | |
Middle name | |
Last name |
Nagoya University Hospital
Department of Cardiac Surgery
052-744-2376
Nagoya University Hospital
Department of Cardiac Surgery
Nagoya University Hospital
Department of Cardiac Surgery
Self funding
NO
2009 | Year | 02 | Month | 05 | Day |
Unpublished
Completed
2004 | Year | 07 | Month | 20 | Day |
2004 | Year | 07 | Month | 01 | Day |
2006 | Year | 05 | Month | 01 | Day |
2007 | Year | 01 | Month | 01 | Day |
2007 | Year | 01 | Month | 01 | Day |
2007 | Year | 12 | Month | 01 | Day |
2009 | Year | 02 | Month | 05 | Day |
2009 | Year | 02 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002037
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