Efficacy of sivelestat sodium administration in perioperative care of abdominal aortic aneurysm with pulmonary function disorder

UMIN ID: UMIN000000650

Registered date:01/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: abdominal aortic aneurysm
• Date of first enrollment: 2007/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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).
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).

Outcome(s)

• Primary Outcome: incidence of postoperative complications, lung injury score, duration of SIRS
• Secondary Outcome: mortality rate, in-hospital days, period in ICU, mechanical ventilation period, each cytokines

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Keio University, School of Medicine Department of Surgery
• Secondary Sponsor: none
• Source(s) of Monetary Support: none,none