Skip to content

The effect of the application of Ulastatin on systemic inflammatory response during perioperative interventional vascular surgery: a single center randomized controlled double-blind study

The effect of the application of Ulastatin on systemic inflammatory response during perioperative interventional vascular surgery: a single center randomized controlled double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097543
Enrollment
Unknown
Registered
2025-02-20
Start date
2025-02-24
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Vascular disease

Interventions

Ulastatin group :Dissolve 5000U/kg of Ulastatin in 100ml of physiological saline and administer it intravenously.Timing of administration: After the surgeon completes the puncture, the infusion is com
Control group :Administer 100ml of physiological saline solution Timing of administration: After the surgeon completes the puncture, the infusion is completed before stent placement

Sponsors

Third Affiliated Hospital of Sun Yat sen University, Guangzhou, Guangdong Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily signed informed consent 2. Age> 18 years old, < 80 years old 3. Patients undergoing elective surgery under general anesthesia who have undergone cerebrovascular intervention 4. No signs of infection before surgery (normal body temperature before operation< 37.3°C; Chest x-ray does not suggest inflammation; White blood cell count (4.0~10.0)×10^9)

Exclusion criteria

Exclusion criteria: a. Emergency surgery, or secondary surgery after admission; b. Preoperative presence of SIRS; c. Suffering from autoimmune diseases, tumors, or receiving high-dose hormones and immunosuppressants within 2 months; d. Congestive heart failure, non-infectious cardiogenic shock, or uncontrolled acute blood loss of New York Heart Association grade 4; e.ASA > Class III f. Previous history of allergy to ulinastatin or any ingredient or preservative; g. Judged by the investigator to be unsuitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Changes in systemic immune inflammatory index (SII) during perioperative period;

Secondary

MeasureTime frame
IL-6;CRP;PQSI;MMSE;VAS;PONV;Incidence rate of SIRS within 3 days post-surgery;

Countries

China

Contacts

Public ContactYao Weifeng

Third Affiliated Hospital of Sun Yat sen University, Guangzhou, Guangdong Province

yaowf3@mail.sysu.edu.cn+86 134 1617 9794

Outcome results

None listed

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