Cardiac shock, respiratory distress syndrome
Conditions
Interventions
Experimental group 1:VA mode ECMO support
Experiemental group 2:VV mode ECMO support
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Inclusion criteria
Inclusion criteria: 1.Single group target value study: 1)=18 years old; 2)Cardiogenic shock caused by various causes; 3)The disease condition of the subject shall meet one of the following conditions: a)Cardiogenic shock with sufficient volume that is difficult to correct with a large number of vasoactive drugs meets at least one of the following criteria:(1)systolic blood pressure 90mmHg;(2)hypoperfusion of terminal organs (urine volume 15mmHg. b)Subjects with cardiogenic shock who, as determined by the investigator, require VA mode support with OASSIST; 4)Obtain the informed consent of the subject or his/her guardian (if subject has no civil capacity). 2.Small sample study 1)=18 years old; 2)ARDS that meet the following criteria: a)Endotracheal intubation and mechanically assisted ventilation =6 days; b)Lung imaging findings showed bilateral infiltrating shadows; c)PaO2/FiO2 3h; b)PaO2/FiO2 36h; c)Arterial blood pH 60 mmHg over 6h; d)Other ARDS subjects who, as determined by the investigator, require VV mode support with OASSIST® equipment. 4)Obtain the informed consent of the subject or his/her guardian (if subject has no civil capacity).
Exclusion criteria
Exclusion criteria: 1.Single group target value study: 1)Irreversible heart failure as determined by the clinician and heart transplantation or VAD implantation is not considered; 2)People who have a history of allergy to extracorporeal circulation lines, blood purification devices and heparin; 3)Those who cannot receive anticoagulant therapy or have contraindications to anticoagulant therapy; 4)People with mental diseases or history, drug addicts, AIDS patients; 5)Terminal state caused by advanced malignant tumor or severe liver, kidney, lung dysfunction; 6)There is active bleeding; 7)Cardiac arrest; 8)Irreversible and severe neurological damage; 9)No intubation access with suitable OASSIST® equipment; 10)Pregnant women; 11)Patients who have participated in other clinical trials within 1 month, and/or are currently participating in other clinical trials and did not reach the trial endpoint; 12)Other conditions were judged by the researcher to be unsuitable for inclusion. 2.Small sample study: 1)Irreversible lung failure judged by the clinician and lung transplantation was not considered; 2)Endotracheal intubation and mechanically assisted ventilation =7 days; 3)Chronic respiratory insufficiency with long-term oxygen therapy and/or long-term respiratory assistance therapy; 4)Heart failure that requires the VA mode of the device that needs to receive the OASSIST® device; 5)Those who have a history of allergy to extracorporeal circulation pipelines, blood purification devices, heparin, etc.; 6)Those who are unable to receive anticoagulation therapy or have contraindications to anticoagulation therapy; 7)Persons with a history of mental illness or illness, drug addicts, AIDS patients; 8)Terminal state caused by advanced malignant tumors or severe liver, kidney, lung insufficiency and other diseases; 9)Presence of active bleeding; 10)Irreversible severe nervous system damage; 11)There is no intubation path for suitable OASSIST® equipment; 12)Pregnant women; 13)Patients who have participated in other clinical trials within 1 month, and/or patients who are currently participating in other clinical trials and have not reached the end point of the trial; 14)Other cases are judged by the researchers to be unsuitable for enrollees.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24h survival rate after weaning; | — |
Secondary
| Measure | Time frame |
|---|---|
| Before the pump pressure;After the pump pressure;Mean arterial pressure;Heart rate;Arterial blood gas analysis;platelet;White blood cells;hematocrit;Posterior membrane pressure;OASSIST Device operation parameters;ECMO-related complications;OASSIST device transfer time;Average length of hospital stay;Average ICU indwelling time;Evaluation of device performance; | — |
Countries
China
Contacts
Public ContactJi Bingyang
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed