Cardiovascular DiseaseNCT04993794
Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
A study testing XueBiJing Injection and Normal saline in people with Cardiovascular Disease and Aortic Dissection, run by Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Disease, Aortic Dissection, Coronary Artery Disease
- What is being tested?
- XueBiJing Injection and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of nanjing medical university
Nanjing, Jiangsu, 210029
Hong Liu, MD, 188012181613, dr.hongliu@foxmail.com
About this study
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
- Being tested
- XueBiJing Injection, Normal saline
- Medical subject headings
- Cardiovascular Diseases, Aortic Dissection, Coronary Artery Disease, Heart Valve Diseases, Heart Defects, Congenital, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XueBiJing InjectionDrug
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.
Normal salineDrug
Same saline dose as XueBiJing injection is taken intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: XueBiJing Injection |
| Normal saline | Placebo comparator | 0.9% saline every 12 h (q12h) for 60 min Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
Measured: up to 30 days after surgery
Secondary outcomes (1)
Highest Sequential Organ Failure Assessment score
Measured: 7 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Liu, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993794
- Sponsor's protocol ID
- 5A-Plan IV
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Anti-inflammatory Action for Critically Ill Patients With Cardiovascular Surgery (Xuebijing) IV
- ClinicalTrials.gov ID
- NCT04993794
- Acronym / sponsor ID
- 5A-Plan IV
- Conditions
- Cardiovascular Disease, Aortic Dissection, Coronary Artery Disease, Valve Heart Disease, Congenital Heart Disease, Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XueBiJing | Active comparator | Drug: XueBiJing InjectionXBJ (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 | Drug: Normal saline0.9% saline every 12 h (q12h) for 60 min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who received cardiovascular surgery fulfilled three or more of the following criteria:
- Agree to participate in the study and sign the informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XueBiJing InjectionXueBiJing, 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. | Drug | XueBiJing |
| Normal salineSame saline dose as XueBiJing injection is taken intravenously. | Drug | Normal saline |
Primary outcome
28-day mortality
Time frame: up to 30 days after surgery
1 secondary outcome
Highest Sequential Organ Failure Assessment score
Time frame: 7 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XueBiJing Injection and Normal saline in people with Cardiovascular Disease and Aortic Dissection, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Liu, MD (18801281613, DR.HONGLIU@FOXMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.