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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XueBiJing | Active Comparator | 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 |
|
| Normal saline | Placebo Comparator | 0.9% saline every 12 h (q12h) for 60 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XueBiJing Injection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Highest Sequential Organ Failure Assessment score | 7 days after randomization |
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Inclusion Criteria:
Patients who received cardiovascular surgery fulfilled three or more of the following criteria:
Agree to participate in the study and sign the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Liu, MD | Contact | 18801281613 | DR.HONGLIU@FOXMAIL.COM | |
| Sheng Zhao, MD | Contact | 02568303105 | zhaosheng0824@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first affiliated hospital of nanjing medical university | Recruiting | Nanjing | Jiangsu | 210029 | China |
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|
| Normal saline | Drug | Same saline dose as XueBiJing injection is taken intravenously. |
|
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000784 | Aortic Dissection |
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D006330 | Heart Defects, Congenital |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D000094683 | Acute Aortic Syndrome |
| D001018 | Aortic Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549376 | Xuebijing |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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