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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    200
  • sponsor
    Nanjing Medical University
Updated on 19 August 2021
vasopressor
cardiopulmonary bypass
cardiovascular surgery

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.

Details
Condition Critical Illness, critically ill, cardiovascular disorders, Coronary Artery Disease, VALVULAR HEART DISEASE, Cardiac Ischemia, Coronary heart disease, Myocardial Ischemia, cardiovascular diseases, cardiovascular disease (cvd), Aortic Dissection, Aneurysm, Congenital Heart Disease, Heart Valve Disease, Cardiovascular Disease, cardiovascular system diseases
Treatment Normal saline, Xuebijing Injection
Clinical Study IdentifierNCT04993794
SponsorNanjing Medical University
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who received cardiovascular surgery fulfilled three or more of the following
Agree to participate in the study and sign the informed consent
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 < 36C or >38.5C
Receiving treatment with vasopressors at therapeutic doses after adequate fluid resuscitation
radiographic findings of new pulmonary infiltrate(s)

Exclusion Criteria

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)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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