Skip to content

The protective effect of Sivirastat sodium on postoperative lung injury in patients undergoing cardiac surgery with concomitant pulmonary hypertension under extracorporeal circulation

The protective effect of Sivirastat sodium on postoperative lung injury in patients undergoing cardiac surgery with concomitant pulmonary hypertension under extracorporeal circulation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109591
Enrollment
Unknown
Registered
2025-09-22
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Heart disease

Interventions

Experimental group (sivelestat sodium group):After induction of anesthesia, sivelestat sodium was continuously pumped intravenously (total amount 4.8 mg/kg mixed with 48ml) at a pumping rate of 1.2 mg
Control group (normal saline group):In the control group, the same volume of normal saline (48 ml) was continuously pumped intravenously after anesthesia induction, and the pumping speed was 12 ml/h u

Sponsors

The First Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective CPB open heart surgery; 2. Preoperative echocardiography estimates pulmonary artery pressure>25mmHg; 3. ASA classification II-IV; 4. Age >= 18 years old, regardless of gender; 5. NYHA classification II-IV; 6. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals who are allergic or contraindicated to Sivirastat sodium and its drug components; 2. Severe heart failure, ASA level V or above; 3. Abnormal liver function: ALT and/or AST exceeding 1.5 times the upper limit of the medical reference range; 4. Abnormal renal function: those whose creatinine exceeds the upper limit of the medical reference range; 5. Patients undergoing secondary surgery; 6. Long term use of immunosuppressants or acquired immunodeficiency syndrome before surgery; 7. Pregnant and lactating women; 8. Patients who refuse to participate in the study.

Design outcomes

Primary

MeasureTime frame
Changes of oxygenation index at 24 hours after operation and oxygenation index before anesthesia induction;

Secondary

MeasureTime frame
Ventilation machine usage time;Duration of stay in intensive care unit;Postoperative hospitalization time;Postoperative extubation time;

Countries

China

Contacts

Public ContactLifang Zhou

The First Affiliated Hospital of Guangxi Medical University

395270146@qq.com+86 183 7881 1663

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026