Extracorporeal Membrane OxygenationECMO-RESCUENCT05184296
ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated
A study testing Extracorporeal Membrane Oxygenation (ECMO) in people with Extracorporeal Membrane Oxygenation and Septic Shock, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Septic Shock, Septic Cardiomyopathy
- What is being tested?
- Extracorporeal Membrane Oxygenation (ECMO)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Patients admitted into ICU and diagnosed as septic shock (sepsis-3.0)13, after adequate fluid resuscitation, high-dose vasoactive drug application [vasoactive inotropic score (VIS) > 120] and conventional therapy together with at least one of the following criteria: (1) sustained hypotension [mean arterial pressure (MAP) < 65 mmHg]; (2) persistent lactacemia (two consecutive values > 5 mmol/L with at least 30 min interval between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors; (3) persistent low mixed venous blood oxygen saturation (SvO2) (two consecutive values < 55% with at least 30 min interval between samples), with non-increasing trend on steady doses of inotropes and/or vasopressors. The above condition lasts more than 5 hours.
- Rapidly deteriorating sepsis-induced myocardial impairment is defined by at least one of the following criteria: (1) rapidly deteriorating ventricular function (LVEF < 35%); (2) cardiac index (CI) < 2L/min/m2 (> 3 hr); (3) emerging refractory arrhythmia.
- Informed consent provided by the patient or person with decisional responsibility.
Who cannot join
- Cardiac dysfunction caused by other causes is excluded, such as acute myocardial infarction, chronic heart failure, congenital cardiac disease, myocardial effusion, moderate to severe aortic regurgitation, severe aortic coarctation and so on.
- High suspicion of pulmonary embolism, tension pneumothorax or cardiac tamponade as a cause of shock.
- Prolonged cardiac arrest (> 30 min) before ECMO, or CPR survivors remaining comatose.
- Irreversible condition or meet the inclusion criteria for more than 12 hr.
- Presence of active bleeding or anticoagulant contraindications.
- Peripheral artery disease disabling insertion of outflow cannula to femoral artery.
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- Irreversible neurological pathology
- Severe underlying condition with lift expectancy less than 1 year.
- Special population, such as pregnancy, acquired immune deficiency syndrome (AIDS).
- Patient included in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chen Weiyan
Guangzhou, Guangdong, 510260
Chen Weiyan, +8613751845652, sam11124@126.com
About this study
Official title: ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE): a Prospective, Multicenter, Non-randomized Cohort Study
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.
Read the detailed description
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.
- Conditions
- Extracorporeal Membrane Oxygenation, Septic Shock, Septic Cardiomyopathy, Cardiogenic Shock
- Being tested
- Extracorporeal Membrane Oxygenation (ECMO)
- Keywords
- Extracorporeal Membrane Oxygenation, refractory septic shock, septic cardiomyopathy, cardiogenic shock
- Medical subject headings
- Shock, Septic, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Membrane Oxygenation (ECMO)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 | Experimental | Participants taking VA-ECMO during the period of study are referred to as cohort 1 Receives: Procedure: Extracorporeal Membrane Oxygenation (ECMO) |
| cohort 2 | No intervention | Patients receiving only conventional therapy without ECMO belong to cohort 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day survival
survival rate at day-30
Measured: From date of enrolled (D0) until date of death from any cause or day-30, whichever came first
Secondary outcomes (9)
ICU survival rate
survival to ICU discharge
Measured: 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
survival to hospital discharge
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: between Day 0 and up to Day 30
ICU length of stay (LOS)
ICU LOS
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhen-hui Zhang, Study director, Second Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184296
- Sponsor's protocol ID
- ICU-02
- Acronym
- ECMO-RESCUE
- Status last verified
- Nov 2023
- First submitted
- 20 Dec 2021
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38858161
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE): a Prospective, Multicenter, Non-randomized Cohort Study
- ClinicalTrials.gov ID
- NCT05184296
- Acronym / sponsor ID
- ECMO-RESCUE / ICU-02
- Conditions
- Extracorporeal Membrane Oxygenation, Septic Shock, Septic Cardiomyopathy, Cardiogenic Shock
- Keywords
- Extracorporeal Membrane Oxygenation, refractory septic shock, septic cardiomyopathy, cardiogenic shock
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cohort 1 | Experimental | Procedure: Extracorporeal Membrane Oxygenation (ECMO)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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 75 years.
- Patients admitted into ICU and diagnosed as septic shock (sepsis-3.0)13, after adequate fluid resuscitation, high-dose vasoactive drug application [vasoactive inotropic score (VIS) > 120] and conventional therapy together with at least one of the following criteria: (1) sustained hypotension [mean arterial pressure (MAP) < 65 mmHg]; (2) persistent lactacemia (two consecutive values > 5 mmol/L with at least 30 min interval between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors; (3) persistent low mixed venous blood oxygen saturation (SvO2) (two consecutive values < 55% with at least 30 min interval between samples), with non-increasing trend on steady doses of inotropes and/or vasopressors. The above condition lasts more than 5 hours.
- Rapidly deteriorating sepsis-induced myocardial impairment is defined by at least one of the following criteria: (1) rapidly deteriorating ventricular function (LVEF < 35%); (2) cardiac index (CI) < 2L/min/m2 (> 3 hr); (3) emerging refractory arrhythmia.
- Informed consent provided by the patient or person with decisional responsibility.
Key exclusion criteria (10 listed)
- Cardiac dysfunction caused by other causes is excluded, such as acute myocardial infarction, chronic heart failure, congenital cardiac disease, myocardial effusion, moderate to severe aortic regurgitation, severe aortic coarctation and so on.
- High suspicion of pulmonary embolism, tension pneumothorax or cardiac tamponade as a cause of shock.
- Prolonged cardiac arrest (> 30 min) before ECMO, or CPR survivors remaining comatose.
- Irreversible condition or meet the inclusion criteria for more than 12 hr.
- Presence of active bleeding or anticoagulant contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Membrane Oxygenation (ECMO)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. | Procedure or surgery | cohort 1 |
Primary outcome
30-day survival
Time frame: From date of enrolled (D0) until date of death from any cause or day-30, whichever came first
survival rate at day-30
9 secondary outcomes
ICU survival rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 6-months
successful rate of ECMO weaning
Time frame: 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
Time frame: at day-30 and 6-month
the number of days alive without CRRT, mechanical ventilation and vasopressor
Time frame: between Day 0 and up to Day 30
ICU length of stay (LOS)
Time frame: 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)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 38858161Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhen-hui Zhang study director
Second Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Membrane Oxygenation (ECMO) in people with Extracorporeal Membrane Oxygenation and Septic Shock, run by Second Affiliated Hospital of Guangzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-yan Chen (+8613751845652, sam11124@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day survival (time frame: From date of enrolled (D0) until date of death from any cause or day-30, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05184296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.