Cardiogenic shock in acute decompensation of chronic heart failure due to coronary heart disease
Conditions
Interventions
Control:Basic therapy+5% glucose injection 50ml continuous intravenous infusion for 4 days by using light-proof micromedicine infusion pump, with the infusion speed of 5ml/h.
Experimental:Basic therapy+Shenfu injection 40ml mix with 5% glucose injection 10ml continuous intravenous infusion for 4 days by using light-proof micromedicine infusion pump, with the infusion speed
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40 and 80 years; 2. Meet the diagnostic criteria of coronary heart disease; 3. Meet the diagnostic criteria of acute decompensation of chronic heart failure; 4. Meet the diagnostic criteria of cardiogenic shock; 5. NYHA classification between III to IV; 6. Under the use of norepinephrine, PiCCO showed that MAP>65mmHg, but GEF<25% or CI<3.0L/min/m2, while PVPI<1.2; 7. Voluntarily signed the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with chronic heart failure who are not due to coronary heart disease; 2. Patients with any of the following diseases: (1) Acute myocarditis; (2) Hypertrophic obstructive cardiomyopathy; (3) Uncontrolled malignant arrhythmias; (4) Severe valvular heart disease requiring surgical treatment; (5) Uncontrolled blood pressure ( SBP>=180mmHg and/or DBP>=110mmHg ); (6) Pulmonary artery embolism; (7) Other diseases that may affect the evaluation of the efficacy and safety of experimental drugs; 3. Patients using intra-aortic balloon counterpulsation; 4. Aggravation of heart failure caused by digitalis poisoning; 5. Diabetic patients with poor blood glucose control within 24 hours before randomization; 6. Accompany by severe primary diseases in liver, renel, hematopoietic system, etc. Or severe disfunction of liver or renel; 7. Pregnant or lactating women; 8. Drug dependence or mental illness; 9. Participating in other clinical trials within nearly three month; 10. Allergy to Shenfu injection, or allergic constitution; 11. To be judged by the researchers that the patient is not appropriate to take part in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PiCCO parameters (GEF, CI, ELWI, GEDI, SVRI, etc.);Incidence of cardiovascular composite end-point events at 28 and 90 days (cardiovascular death, abandon treatment due to deterioration of heart failure, successful resuscitation after cardiac arrest, malignant arrhythmia, re-hospitalization in ICU/CCU because of aggravated heart failure); | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA classification;NT-proBNP;SOFA score;Lee's heart failure score;Norepinephrine dosage;Echocardiography; | — |
Countries
China
Contacts
Public ContactShaoxiang Xian
Outcome results
None listed