Skip to content

A randomized controlled trial for the efficacy and safety of injection of Yiqi Fumai for septic shock and cardiogenic shock

A randomized controlled trial for the efficacy and safety of injection of Yiqi Fumai for septic shock and cardiogenic shock

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026424
Enrollment
Unknown
Registered
2019-10-09
Start date
2019-10-15
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock and cardiogenic shock

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients with septic shock (1) all the patients met the clinical diagnostic criteria for septic shock, with clear infection foci and the growth of pathogenic microorganisms in blood culture; (2) body temperature over 38.5 degree C or below 35 degree C; (3) hypoperfusion of tissues and organs, urine volume less than 0.5ml /(h.kg); (4) systolic blood pressure lower than 90 mmHg; (5) SOFA score greater than 2, (6) vasoactive drugs are required to maintain MAP 65mmHg; Blood lactic acid tendency for L > 2. (7) all patients or their families have given informed consent and signed informed consent forms; (8) complete clinical diagnosis and treatment data and follow-up data. 2.Patients with cardiogenic shock: according to the guidelines for diagnosis and treatment of cardiogenic shock formulated in 2010. (1) patients with a history of acute myocardial infarction, acute myocarditis, primary or secondary cardiomyopathy, severe malignant arrhythmia, drug poisoning with myocardial toxicity, acute cardiac compression and cardiac surgery; (2) in the early stage, the patient was agitated, pale, complained of dry mouth and sweating, but still had a clear mind; Gradually after the expression of indifference, fuzzy consciousness, delirious until coma; (3) the heart rate gradually increased during physical examination, often > 120 times /min. Systolic blood pressure < 80 mmHg, pulse pressure difference < 20mmHg, then gradually decreased, serious blood pressure can not be measured. A weak pulse, cold extremities, cyanosis of the extremities, and variegated skin. Heart tone low pure, serious show single tone. Urine volume < 17mL/h, or even no urine. In the late stage of shock, extensive bleeding of skin, mucosa and viscera, i.e. diffuse intravascular coagulation, and multiple organ failure occurred. (4) hemodynamic monitoring suggested the corresponding hemodynamic abnormalities such as decreased cardiac index and increased left ventricular end-diastolic pressure. (5) patients aged between 18 and 70 years.

Exclusion criteria

Exclusion criteria: 1.Confirmed chronic uremia or died or left the hospital 24 hours after admission; 2.Patients with severe cirrhosis, advanced tumors or abnormal coagulation; 3.Patients with a history of stress ulcer or severe craniocerebral injury within 6 months; 4.Autoimmune diseases and malignant tumors; 5.Allergic to red ginseng, radix ophiopogonis, schisandrae and other traditional Chinese medicines and injection preparations.

Design outcomes

Primary

MeasureTime frame
Hemodynamic monitoring;Lactate clearance rate;

Secondary

MeasureTime frame
Sepsis related sexual organ failure score (SOFA);Acute physiology and chronic health score II (APACHE II);Inflammatory cytokines;Immune function index;

Countries

China

Contacts

Public ContactChen Bojun

The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

1198039070@qq.com+86 13760655545

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026