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

NCT04993794 | Unknown

• 1 other identifier: 5A-Plan IV
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Aortic Dissection; Coronary Artery Disease; Valve Heart Disease; Congenital Heart Disease; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  up to 30 days after surgery

Secondary Outcomes (1)

• Highest Sequential Organ Failure Assessment score

  7 days after randomization

Study Arms (2)

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

Drug: XueBiJing Injection

Normal saline

PLACEBO COMPARATOR

0.9% saline every 12 h (q12h) for 60 min

Drug: Normal saline

Interventions

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.

XueBiJing

Normal saline DRUG

Same saline dose as XueBiJing injection is taken intravenously.

Normal saline

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The first affiliated hospital of nanjing medical university

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Aortic Dissection; Coronary Artery Disease; Heart Valve Diseases; Heart Defects, Congenital; Critical Illness

Interventions

Xuebijing; Saline Solution

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Hong Liu, MD

CONTACT

18801281613; DR.HONGLIU@FOXMAIL.COM

Sheng Zhao, MD

CONTACT

02568303105; zhaosheng0824@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Cardiovascular Surgery

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 10, 2021

Record last verified: 2021-08

Locations

CN (1)