Clinical trial NCT04993794: Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
Official title: Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Aortic Dissection
Coronary Artery Disease
Valve Heart Disease
Congenital Heart Disease
Critical Illness
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: 28-day mortality
timeFrame: up to 30 days after surgery
Secondary outcomes:
measure: Highest Sequential Organ Failure Assessment score
timeFrame: 7 days after randomization
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The first affiliated hospital of nanjing medical university
state: Jiangsu
Study officials:
References: