Circulation insufficiency and (or) respiratory insufficiency
Conditions
Interventions
VA Group:Use VA model of Microport surgery of the ECMO for treatment
VV Group:Use VV model of Microport surgery of the ECMO for treatment
Sponsors
Beijing Anzhen Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: VA model group: 1. The age of 18 years old or more. 2. Cardiogenic shock due to various causes (refractory low cardiac output after cardiac surgery, myocarditis, myocardial infarction, heart failure or cardiomyopathy). 3. The subjects disease conditions must meet the following one: 1) Volumetrically adequate cardiogenic shock that is refractory to correction despite treatment with optimized vasoactive medications, meeting at least one of the following criteria: a) systolic blood pressure 90mmHg; b) evidence of hypoperfusion in end-organs (altered state of consciousness, urine output 15mmHg. 2) other patients with cardiogenic shock who were deemed by the investigator to be suitable for ECMO VA support. 4. Informed consent was obtained from subjects or their guardians (if subjects have no capacity for civil conduct). VV mode group: 1. Age =18 years old. 2. Acute respiratory failure caused by various reasons. 3. The subject's disease condition must meet the following: 1) ARDS and meets the following criteria: A) endotracheal intubation and mechanical assisted ventilation 60 mmHg for more than 6 hours. 4. Other cases by the researchers think, is needed for the ECMO VV schema support ARDS patients. 5. Informed consent was obtained from the subjects or their guardians (if the subjects have no capacity for civil conduct).
Exclusion criteria
Exclusion criteria: VA model group: 1. Don't consider long-term ventricular assist device implantation or irreversible cardiac failure; Or not to consider transplantation of irreversible lung function failure. 2. The irreversible serious brain damage and/or irreversible nerve damage. 3. Cardiac arrest or cardiopulmonary resuscitation for more than 30 minutes. 4. Long severe metabolic acidosis, such as lactic acid > 10 tendency for more than 10 h/L. 5. Late malignant tumor or severe liver and kidney not congruent disease causes of terminal state; Irreversible multiple organ failure; Patients with mental illness or medical history, drug users, AIDS patients. 6. Merger exists serious coagulation disorder or anticoagulation contraindicated (such as active bleeding, liver dysfunction), etc. 7. Combined with moderate-severe aortic insufficiency and acute aortic dissection aneurysm. 8. Poor vascular condition or unsuitable for catheterization or no suitable type of pipeline (e.g., severe peripheral artery disease, obesity, amputation). 9. Catheter can not reach the designated position or serious complications appeared in the process of catheter (again or intervened incision surgery, vascular complications) or other tube failure (need to retain video evidence (if applicable)). 10. Older age (> 75 years), pregnancy, heparin, or line, membrane allergic lung materials. 11. Other patients deemed ineligible for enrollment or interfering with the trial results. 12. 1 month participated in other clinical trials, or is in the primary end point,. VV group in addition to the above rule out standard, but also need: 1. Require long-term breathing machine auxiliary treatment of chronic respiratory insufficiency. 2. Endotracheal intubation and mechanical ventilation for =7 days. 3. Need to accept the VA model of heart failure; Other conditions were not suitable for VV mode according to the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate at 24 hours after weaning; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ECMO system performance index;Device performance evaluation;Performance of ECMO system;The average ICU length of hospital stay;Average length of hospital stay; | — |
Countries
China
Contacts
Public ContactXiaotong Hou
Beijing Anzhen Hospital,Capital Medical University
Outcome results
None listed