NCT04993794

Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

XueBiJing, a Chinese herbal derived therapeutic, has been approved to treat severe infections (sepsis) in critically ill patients (China Food and Drug Administration; Beijing, China, Number Z20040033). Cardiopulmonary bypass (CPB) will produce large amounts of inflammatory mediators and oxygen free radicals, which causes the lipid peroxidation damage and mononuclear cell migration, thus aggravating organ inflammation and damage. Therefore, exploring new methods to prevent and alleviate organ injury caused by CPB is an important topi in clinical practice. However, little knowledge is regarding the effect of Xuebijing injection on CPB-related organ injury. To answer these questions, the authors conducted this randomized trial to compare XueBiJing with placebo in critically ill patients with cardiovascular surgery.

Conditions

• Cardiovascular Disease
• Aortic Dissection
• Coronary Artery Disease
• Valve Heart Disease
• Congenital Heart Disease
• Critical Illness

Interventions

Type	Name	Description
DRUG	XueBiJing Injection	XueBiJing, specification 10mL/ampule, packaging 10 ampules/container, concentration 0.1g/mL, were manufactured by a Good Manufacturing Practice certified company in China (Tianjin Chase Sun Pharmaceutical Co., Tianjin, China; China lot number 1304291, 1401091 and, 1501261). Generally, the treatment duration of the study was at least 5 days.
DRUG	Normal saline	Same saline dose as XueBiJing injection is taken intravenously.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-08-06
• Last updated: 2021-08-10

Locations

1 site across 1 country: China