UMIN ID: UMIN000001687
Registered date:05/02/2009
A pilot randomized placebo controlled study of the Neutrophil Elastase Inhibitor, Sivelestat, in Patients Undergoing Cardiac Surgery
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | coronary artery bypass patients |
| Date of first enrollment | 2004/07/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Continuous intravenous administration of the neutrophil erastase inhibitor Continuous intravenous administration of isotonic sodium chloride solution |
Outcome(s)
| Primary Outcome | Completeness of the study in enrolled patients. Peri-operative morbidity |
|---|---|
| Secondary Outcome | Clinical outcomes such as lenghts of hospital stay. Pulmonary function |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Patients requiring either preoperative intravenous inotropic or vasodilative drugs, intraaortic balloon support, supplemental oxygen, or mechanical ventilation |
Related Information
| Primary Sponsor | Nagoya University Hospital Department of Cardiac Surgery |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Nagoya University Hospital Department of Cardiac Surgery |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 052-744-2376 |
| Affiliation | Nagoya University Hospital Department of Cardiac Surgery |
| scientific contact | |
| Name | Yuichi Ueda |
| Address | 65 Tsurumai-cho, Showa-ku, Nagoya Japan |
| Telephone | 052-744-2376 |
| Affiliation | Nagoya University Hospital Department of Cardiac Surgery |