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

Nanjing Medical University

Status: Unknown

Conditions: Coronary Artery Disease; Valve Heart Disease; Critical Illness; Congenital Heart Disease; Aortic Dissection; Cardiovascular Disease

Treatments: Drug: Normal saline; Drug: XueBiJing Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04993794

5A-Plan IV

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

XueBiJing

Active Comparator group

Description:

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

Treatment:

Drug: XueBiJing Injection

Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline