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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993794
• Other study ID #: 5A-Plan IV
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Nanjing Medical University
• Contact: Hong Liu, MD
• Phone: 18801281613
• Email: DR.HONGLIU[@]FOXMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients who received cardiovascular surgery fulfilled three or more of the following criteria:

• Pao2/Fio2 ratio less than or equal to 250mm Hg,

• Respiratory rate greater than or equal to 30 breaths/min,

• Blood urea nitrogen greater than 20mg/dL,

• WBC count < 4,000 cells/mm3 or >15 000 cells/mm3 not due to other causes,

• Core temperature < 36°C or >38.5°C,

• Receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation,

• radiographic findings of new pulmonary infiltrate(s).

2. Agree to participate in the study and sign the informed consent.

Exclusion Criteria:

1. Pregnant and lactating women.

2. Allergic to Xuebijing and its ingredients, or have severe allergies.

3. Mental illness with poor compliance.

4. Severe primary disease (active pulmonary tuberculosis, asthma, cystic pulmonary fibrosis, pulmonary sarcoidosis, pulmonary interstitial fibrosis, unresectable tumors, blood diseases, Alzheimer s disease, or HIV).

5. Participation in other clinical trials in the previous 30 days.

6. Patients who are unsuitable for participation or unable to participate in this trial according to the judgment of the investigators (existing risk of potential medical disputes, and severe heart failure limiting the amount of liquid intake).

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection
• Cardiovascular Disease
• Cardiovascular Diseases
• Congenital Heart Disease
• Coronary Artery Disease
• Critical Illness
• Heart Defects, Congenital
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

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.
• Normal saline
Same saline dose as XueBiJing injection is taken intravenously.

Locations

Country	Name	City	State
China	The first affiliated hospital of nanjing medical university	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality		up to 30 days after surgery
Secondary	Highest Sequential Organ Failure Assessment score		7 days after randomization