Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- 28-day mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
- •Agree to participate in the study and sign the informed consent.
排除标准
- •Pregnant and lactating women.
- •Allergic to Xuebijing and its ingredients, or have severe allergies.
- •Mental illness with poor compliance.
- •Severe primary disease (active pulmonary tuberculosis, asthma, cystic pulmonary fibrosis, pulmonary sarcoidosis, pulmonary interstitial fibrosis, unresectable tumors, blood diseases, Alzheimer s disease, or HIV).
- •Participation in other clinical trials in the previous 30 days.
- •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).
研究组 & 干预措施
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
干预措施: XueBiJing Injection (Drug)
Normal saline
0.9% saline every 12 h (q12h) for 60 min
干预措施: Normal saline (Drug)
结局指标
主要结局
28-day mortality
时间窗: up to 30 days after surgery
次要结局
- Highest Sequential Organ Failure Assessment score(7 days after randomization)
研究者
Hong Liu
Principal Investigator of Cardiovascular Surgery
Nanjing Medical University