The impact of perioperative administration of sivelestat sodium on liver and kidney function in patients undergoing cardiac surgery in the early postoperative period

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400092841

Enrollment

Unknown

Registered

2024-11-25

Start date

2024-12-01

Completion date

Unknown

Last updated

2024-12-02

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):Dissolve 4.8 mg/kg of sivelestat sodium in 40 ml of physiological saline, divide it into two equal of 20 ml each, and start pumping one dose after anesthe

Control group (physiological saline group):Divide 40 ml of normal saline into two equal doses of 20 ml each, with one dose starting to be infused after anesthesia until the end of surgery, and the oth

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective cardiac surgery; 2. ASA grading I-III; 3. Cardiac function levels I-III; 4. Age = 18 years old, = 65 years old, gender not limited; 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of allergy to sivelestat sodium in the past; 2. History of liver, kidney, and heart surgeries in the past; 3. Combination of chronic respiratory diseases, immune diseases, and hematological diseases; 4. Preoperative pulmonary hypoxia, pulse oxygen saturation<90%, or arterial oxygen partial pressure<60 mmHg; 5. The patient is currently taking immunosuppressants, hormone drugs, or in an active rheumatic infection period; 6. Severe liver and kidney dysfunction (AST/ALT exceeding the upper limit of normal by 1.5 times, serum creatinine exceeding twice the normal baseline level).

Design outcomes

Secondary

Measure	Time frame
Intraoperative observation indicators;Record intraoperative urine output and 24-hour urine output on postoperative days 1 and 2;Preoperative and postoperative 24-hour venous blood testing for plasma IL-6;Postoperative recovery quality;Detecting total bilirubin, AST, ALT, urea, and creatinine before surgery, 24 hours after surgery, and 48 hours after surgery;	—

Primary

Measure	Time frame
Serum creatinine at 48 hours postoperatively;	—

Countries

China

Contacts

Public ContactYanhua Chen

The First Affiliated Hospital of Guangxi Medical University

402009694@qq.com+86 139 7885 8025

Outcome results

None listed

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