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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000650
Enrollment
40
Registered
2007-05-01
Start date
2007-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abdominal aortic aneurysm

Interventions

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

Sponsors

Keio University, School of Medicine Department of Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The participants should be over 20 years old and should have written consent to participate in the trial. Patients with the P/F ratio of less than 300mmHg and the chest X-ray showing bilateral infiltration shadow during the operation will be included in the trial, because at the moment, administration of sivelestat sodium is covered by the insurance only for patients with the acute lung injury.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
incidence of postoperative complications, lung injury score, duration of SIRS

Secondary

MeasureTime frame
mortality rate, in-hospital days, period in ICU, mechanical ventilation period, each cytokines

Countries

Japan

Contacts

Public ContactObara Hideaki

Keio University, School of Medicine Department of Surgery

obara@sc.itc.keio.ac.jp03-3353-1211(62334)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026