Acute heart failure and cardiogenic shock
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participated and signed an informed consent form; 2. Aged >= 18 years; 3. Acute heart failure or cardiogenic shock with one of the following diagnoses: (1) Hemodynamic instability makes it impossible to determine whether it is clear that other long-term treatments can be used or whether heart transplantation can be used; (2) Those who cannot leave the cardiopulmonary bypass after heart surgery; (3) Various reasons cause end-stage heart failure waiting for bridging before heart transplantation; (4) Severe cardiac dysfunction caused by acute myocardial infarction or fulminant myocarditis; (5) The use of other mechanical circulation aids (such as IABP, ECMO, etc.) cannot maintain the circulation or has complications; (6) The circulation is unstable after cardiopulmonary resuscitation; (7) Acute rejection of the graft after heart transplantation causes circulatory instability; (8) Right heart failure occurs after mechanical assistance of the left ventricle; 4. Left ventricle or right ventricle or double ventricle extracorporeal mechanical circulation assisted hemodynamic standards (it is sufficient to meet one of them): (1) Hemodynamic standards for left ventricular assistance: 1) Heart output index (CI)=18mmHg ; 3) Pulmonary artery diastolic pressure (PADP)>=18mmHg ; 4) Left atrial pressure (LAP)>=18mmHg; (2) Hemodynamic standards for right ventricle or double ventricle assistance: 1) Central venous pressure (CVP) >=15mmHg ; 2) Right atrial pressure (RAP) >=15mmHg ; 3) Right ventricular stroke work (RVSW) <=4.1gm.m2/stroke; (3) Or, patients whose hemodynamic indicators cannot be measured due to special circumstances such as frequent arrhythmia, severe cardiac dysfunction, hemodynamic instability, but clinical experience has determined that they need extracorporeal mechanical circulation assistance; 5. The authorized clinician confirms that all possible measures have been tried to correct arterial blood gas abnormalities, electrolyte disturbances, hypovolemia, hypervolemia, bradycardia, arrhythmia, and incomplete rewarming.
Exclusion criteria
Exclusion criteria: 1. Irreversible central nervous system damage has occurred; 2. Patients with severe infections, malignant tumors, end-stage multiple organ failure, allergies, and severe anemia; 3. Blood urea nitrogen (BUN) > 100 mg/dl. (based on laboratory test data within 24 hours before enrollment); 4. Creatinine (Cr) > 5 mg/dl (based on laboratory test data within 24 hours before enrollment); 5. Have a known history of liver cirrhosis or portal hypertension; 6. Patients with severe pulmonary embolism or pulmonary infarction caused by pulmonary embolism or uncorrectable pulmonary hypertension on pulmonary angiography within two weeks; 7. Patients with mental illness or medical history, drug users, HIV, and syphilis-positive patients; A history of stroke, transient ischemic attack or any of these conditions within 8.6 months; 9.Patients with active bleeding or coagulation disorders; 10. Patients who cannot tolerate anticoagulation or antiplatelet therapy (such as heparin or similar substitutes) or any other perioperative treatment measures required by the researcher according to the patient's condition; 11. Patients who have implanted any mechanical heart valve; 12. The investigator determines that the patient has a disease that does not apply to the external ventricular assist system; 13. Female patients during pregnancy; 14. Patients who have participated in other clinical trials within 1 month, and/or are currently participating in other clinical trials and have not reached the end of the trial; 15. The investigator believes that it is not suitable for patients participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of assist; | — |
Countries
China
Contacts
Union Hospital,Tongji Medical College,Huazhong University of Science and Technology