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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Cardiovascular Disease; Critical Illness; Congenital Heart Disease; Aortic Dissection; Valve Heart Disease
• Intervention / Treatment: Drug: XueBiJing Injection; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: XueBiJing Injection; 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.
Placebo Comparator: Normal saline; 0.9% saline every 12 h (q12h) for 60 min	Drug: Normal saline; Same saline dose as XueBiJing injection is taken intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
28-day mortality	up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Highest Sequential Organ Failure Assessment score	7 days after randomization

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Congenital Abnormalities; Coronary Disease; Cardiovascular Abnormalities; Aneurysm; Heart Diseases; Coronary Artery Disease; Cardiovascular Diseases; Critical Illness; Heart Defects, Congenital; Aneurysm, Dissecting; Heart Valve Diseases
• Other Study ID Numbers: 5A-Plan IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No