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

NCT ID: NCT04993794

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

XueBiJing

XBJ (Composed of Carthamus tinctorius L., Paeonia Lactifora Pall, Ligusticum wallichii, Salvia miltiorrhiza, Angelica sinensis, etc. Tianjin Chase Sun Pharmaceutical Group, Tianjin, China, batch No. 1603231) 100ml Xuebijing injection every 12 h (q12h) for 60 min

Group Type: ACTIVE_COMPARATOR

XueBiJing Injection

Intervention Type: DRUG

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

0.9% saline every 12 h (q12h) for 60 min

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Same saline dose as XueBiJing injection is taken intravenously.

Interventions

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.

Intervention Type: DRUG

Normal saline

Same saline dose as XueBiJing injection is taken intravenously.

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hong Liu

Principal Investigator of Cardiovascular Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hong Liu, MD

Role: CONTACT

DR.HONGLIU@FOXMAIL.COM

18801281613

Sheng Zhao, MD

Role: CONTACT

zhaosheng0824@163.com

02568303105

Facility Contacts

Hong Liu, MD

Role: primary

dr.hongliu@foxmail.com

188012181613

Other Identifiers

5A-Plan IV

Identifier Type: -

Identifier Source: org_study_id