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

Primary Purpose

Cardiovascular Disease, Aortic Dissection, Coronary Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

XueBiJing Injection

Normal saline

About this trial

This is an interventional treatment trial for Cardiovascular Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

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).

Sites / Locations

The first affiliated hospital of nanjing medical universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

XueBiJing

Normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

28-day mortality

Secondary Outcome Measures

Highest Sequential Organ Failure Assessment score

Full Information

NCT ID

NCT04993794

First Posted

July 29, 2021

Last Updated

August 9, 2021

Sponsor

Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04993794

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XueBiJing

Arm Type

Active Comparator

Arm Description

Arm Title

Normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

XueBiJing Injection

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Same saline dose as XueBiJing injection is taken intravenously.

Primary Outcome Measure Information:

Title

28-day mortality

Time Frame

up to 30 days after surgery

Secondary Outcome Measure Information:

Title

Highest Sequential Organ Failure Assessment score

Time Frame

7 days after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hong Liu, MD

Phone

18801281613

DR.HONGLIU@FOXMAIL.COM

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng Zhao, MD

Phone

02568303105

zhaosheng0824@163.com

Facility Information:

Facility Name

The first affiliated hospital of nanjing medical university

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hong Liu, MD

Phone

188012181613

dr.hongliu@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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