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The ECMO-RESCUE study is a prospective, multicenter, non-randomized, cohort study. In this study, we aimed to assessed whether VA-ECMO treatment can improve the 30-day survival rate of patients with sepsis-induced refractory cardiogenic shock.
All patients who meet inclusion criteria and have no exclusion criteria are considered to be enrolled. During the period of study, the participants can decide whether to accept ECMO based on their personal conditions. If a patient is willing to accept ECMO treatment, we initiate VA-ECMO within 6 hours. Participants taking VA-ECMO during the period of study are referred to as cohort 1, and patients receiving only conventional therapy without ECMO belong to cohort 2. 30-day survival will be accessed to evaluate the survival benefit from ECMO therapy for sepsis-induced refractory cardiogenic shock.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Experimental | Participants taking VA-ECMO during the period of study are referred to as cohort 1 |
|
| cohort 2 | No Intervention | Patients receiving only conventional therapy without ECMO belong to cohort 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Membrane Oxygenation (ECMO) | Procedure | All patients in cohort 1 will initiate ECMO as fast as possible. A maximum of 6 hours is allowed between enrollment and the actual initiation of ECMO. ECMO catheterization and management will be operated by an experienced ECMO team and carried out at the bedside. VA or VAV mode will be chosen according to the patient's condition. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day survival | survival rate at day-30 | From date of enrolled (D0) until date of death from any cause or day-30, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| ICU survival rate | survival to ICU discharge | From date of enrolled (D0) until date of death from any cause or date of discharge from ICU, whichever came first, assessed up to 6 months |
| hospital survival |
| Measure | Description | Time Frame |
|---|---|---|
| safety assessments | the rate of complications potentially related to ECMO treatment, including major bleeding associated with anticoagulants, thrombosis, leg ischemia and cannulation-related injuries. | from the date of enrolled (D0) until death or day-30, whichever came first. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-yan Chen | Contact | +8613751845652 | sam11124@163.com | |
| De-liang Wen | Contact | +8618126780249 | deliangwen@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhen-hui Zhang | Second Affiliated Hospital of Guangzhou Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chen Weiyan | Recruiting | Guangzhou | Guangdong | 510260 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38858161 | Derived | Chen WY, Guo ZB, Kong TY, Chen WX, Chen XH, Yang Q, Wen YC, Wen QR, Zhou F, Xiong XM, Wen DL, Zhang ZH. ExtraCorporeal Membrane Oxygenation in the therapy for REfractory Septic shock with Cardiac function Under Estimated (ECMO-RESCUE): study protocol for a prospective, multicentre, non-randomised cohort study. BMJ Open. 2024 Jun 10;14(6):e079212. doi: 10.1136/bmjopen-2023-079212. |
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|
survival to hospital discharge
| From date of enrolled (D0) until date of death from any cause or date of discharge from hospital, whichever came first, assessed up to 6 months |
| 6-month survival | survival rate at 6-month | From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first |
| quality of life for long-term survival | evaluate through EuroQol Five Dimensions Questionnaire Descriptive System at 6-month within survivors, the minimum value is 3, the maximum value is 15, higher scores mean a worse state. | at 6-months |
| successful rate of ECMO weaning | Successful weaning is defined as maintaining stable condition within 24 hours of ECMO weaning. Analyzed the frequency of patients who weaning ECMO successfully | From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first |
| long-term survivors' cardiac function | LVEF evaluated according to Doppler echocardiography | at day-30 and 6-month |
| the number of days alive without CRRT, mechanical ventilation and vasopressor | the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days | between Day 0 and up to Day 30 |
| ICU length of stay (LOS) | ICU LOS | From date of enrolled (D0) until the date of death from any cause or discharge from ICU, whichever came first, assessed up to 6 month |
| hospital length of stay (LOS) | hospital LOS | From date of enrolled (D0) until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 6 month |
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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