Cardiogenic ShockNCT04158479
China Extracorporeal Life Support Registry
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiogenic Shock, Cardiac Arrest, Heart Failure
- What is being tested?
- ECMO
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving ECMO for circulatory and/or respiratory support
Who may be able to join
- Patients receiving ECMO for circulatory and/or respiratory support
Who cannot join
- Refusal of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Xiaotong Hou, MD., PhD., 8610 64456631, xt.hou@ccmu.edu.cn
Xiaotong Hou, MD., PhD.
About this study
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.
This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.
Read the detailed description
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.
The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.
This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. Data were submitted by the following member institutions:
AFFILIATED HOSPITAL OF GUANGDONG MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF JINING MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF NANTONE UNIVERSITY, AFFILIATED HOSPITAL OF ZUNYI MEDICAL UNIVERSITY, ANHUI PROVINCIAL HOSPITAL, BEIJING ANZHEN HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHILDREN'S HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BINZHOU MEDICAL UNIVERSITY HOSPITAL, CHANGHAI HOSPITAL, CHILDREN'S HOSPITAL OF SHANGHAI JIAOTONG UNIVERSITY, CHINESE PLA GENERAL HOSPITAL, DALIAN CENTRAL HOSPITAL, DONGGUAN PEOPLE'S HOSPITAL, FIRST AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY, FUJIAN PROVINCIAL HOSPITAL, FUZHOU PULMONARY HOSPITAL OF FUJIAN, GENERAL HOSPITAL OF NINGXIA MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL PEOPLES HOSPITAL, HAINAN GENERAL HOSPITAL, HENAN PROVINCIAL CHEST HOSPITAL, HENAN PROVINCIAL PEOPLES HOSPITAL, NINGBO FIRST HOSPITAL (NINGBO HOSPITAL OF ZHEJIANG UNIVERSITY, PEKING UNION MEDICAL COLLEGE HOSPITAL, PEKING UNIVERSITY PEOPLE'S HOSPITAL, PEKING UNIVERSITY THIRD HOSPITAL, SHANXI PROVINCIAL PEOPLE'S HOSPITAL, SHENGJING HOSPITAL OF CHINAMESICAL UNIVERSITY, SHUNDE HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY, SUZHOU MUNICIPAL HOSPITAL, TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE, THE 2ND AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY, THE AFFILIATED HOSPITAL OF HANGZHOU NORMAL UNIVERSITY, THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY, THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY, THE CHILDREN'S HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY, THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVESITY, THE FIRST HOSPITAL AFFILIATED TO AMU (SOUTHWEST HOSPITAL), THE FIRST HOSPITAL OF LANZHOU UNIVERSITY, THE FIRST HOSPITAL OF ZHEJIANG PROVINCE, THE FIRST PEOPLE'S HOSPITAL OF YUEYANG, THE NORTHERN JIANGSU PEOPLES HOSPITAL, THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTONOMOUS REGION, THE SECOND AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE SECOND HOSPITAL OF JILIN UNIVERSITY, THE SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY, THE SIXTH MEDICAL CENTER OF PLA GENERAL HOSPITAL, THE THIND AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY, WEST CHINA HOSPITAL,SICHUAN UNIVERSITY, WUHAN ASIA HEART HOSPITAL, WUHAN JINYINTAN HOSPITAL, WUHAN UNION HOSPITAL, XIANGYIA HOSPITAL CENTRAL SOUTH UNIVERSITY, XIJING HOSPITAL, ZHEJIANG PROVINCE PEOPLE'S HOSPITAL, ZHON GNAN HOSPITAL OF WUHAN UNIVERSITY, ZHONGDA HOSPITAL SOUTHEAST UNIVERSITY, ZHONGSHAN HOSPITAL
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Heart Failure, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Being tested
- ECMO
- Medical subject headings
- Shock, Cardiogenic, Heart Arrest, Heart Failure, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMODevice
ECMO for circulatory and/or respiratory support
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Support | ECMO support for acute respiratory failure, ARDS Receives: Device: ECMO | |
| Cardiac Support | ECMO support for heart failure, cardiogenic shock Receives: Device: ECMO | |
| Extracorporeal Cardiopulmonary Resuscitation | ECMO support for cardia arrest Receives: Device: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days
Secondary outcomes (5)
All-cause mortality
Measured: 365 days
Rate of successful weaning from ECMO
Measured: 30 days
ECMO-related complications
Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change
Measured: 30 days
Other complications
Acute renal failure, ulcer bleeding, pneumonia, sepsis
Measured: 30 days
Duration stay at ICU and hospital
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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 Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158479
- Sponsor's protocol ID
- 2019040X
- Status last verified
- Apr 2024
- First submitted
- 7 Nov 2019
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yuan Z, Liu Y, Wei G, Wang F, Yao B, Hou X, Xing J. Clinical characteristics of extracorporeal cardiopulmonary resuscitation in China: a multicenter retrospective study. BMC Anesthesiol. 2024 Jul 10;24(1):230. doi: 10.1186/s12871-024-02618-2.
PubMed 38987696
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Extracorporeal Life Support Registry
- ClinicalTrials.gov ID
- NCT04158479
- Acronym / sponsor ID
- 2019040X
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Heart Failure, Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Nov 2019 (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.
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.
This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.
Detailed description
Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.
The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.
This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. Data were submitted by the following member institutions:
AFFILIATED HOSPITAL OF GUANGDONG MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF JINING MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF NANTONE UNIVERSITY, AFFILIATED HOSPITAL OF ZUNYI MEDICAL UNIVERSITY, ANHUI PROVINCIAL HOSPITAL, BEIJING ANZHEN HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHILDREN'S HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BINZHOU MEDICAL UNIVERSITY HOSPITAL, CHANGHAI HOSPITAL, CHILDREN'S HOSPITAL OF SHANGHAI JIAOTONG UNIVERSITY, CHINESE PLA GENERAL HOSPITAL, DALIAN CENTRAL HOSPITAL, DONGGUAN PEOPLE'S HOSPITAL, FIRST AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY, FUJIAN PROVINCIAL HOSPITAL, FUZHOU PULMONARY HOSPITAL OF FUJIAN, GENERAL HOSPITAL OF NINGXIA MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL PEOPLES HOSPITAL, HAINAN GENERAL HOSPITAL, HENAN PROVINCIAL CHEST HOSPITAL, HENAN PROVINCIAL PEOPLES HOSPITAL, NINGBO FIRST HOSPITAL (NINGBO HOSPITAL OF ZHEJIANG UNIVERSITY, PEKING UNION MEDICAL COLLEGE HOSPITAL, PEKING UNIVERSITY PEOPLE'S HOSPITAL, PEKING UNIVERSITY THIRD HOSPITAL, SHANXI PROVINCIAL PEOPLE'S HOSPITAL, SHENGJING HOSPITAL OF CHINAMESICAL UNIVERSITY, SHUNDE HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY, SUZHOU MUNICIPAL HOSPITAL, TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE, THE 2ND AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY, THE AFFILIATED HOSPITAL OF HANGZHOU NORMAL UNIVERSITY, THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY, THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY, THE CHILDREN'S HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY, THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVESITY, THE FIRST HOSPITAL AFFILIATED TO AMU (SOUTHWEST HOSPITAL), THE FIRST HOSPITAL OF LANZHOU UNIVERSITY, THE FIRST HOSPITAL OF ZHEJIANG PROVINCE, THE FIRST PEOPLE'S HOSPITAL OF YUEYANG, THE NORTHERN JIANGSU PEOPLES HOSPITAL, THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTONOMOUS REGION, THE SECOND AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE SECOND HOSPITAL OF JILIN UNIVERSITY, THE SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY, THE SIXTH MEDICAL CENTER OF PLA GENERAL HOSPITAL, THE THIND AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY, WEST CHINA HOSPITAL,SICHUAN UNIVERSITY, WUHAN ASIA HEART HOSPITAL, WUHAN JINYINTAN HOSPITAL, WUHAN UNION HOSPITAL, XIANGYIA HOSPITAL CENTRAL SOUTH UNIVERSITY, XIJING HOSPITAL, ZHEJIANG PROVINCE PEOPLE'S HOSPITAL, ZHON GNAN HOSPITAL OF WUHAN UNIVERSITY, ZHONGDA HOSPITAL SOUTHEAST UNIVERSITY, ZHONGSHAN HOSPITAL
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Support | – | Device: ECMOECMO support for acute respiratory failure, ARDS |
| Cardiac Support | – | Device: ECMOECMO support for heart failure, cardiogenic shock |
| Extracorporeal Cardiopulmonary Resuscitation | – | Device: ECMOECMO support for cardia arrest |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving ECMO for circulatory and/or respiratory support
Key inclusion criteria (1 listed)
- Patients receiving ECMO for circulatory and/or respiratory support
Key exclusion criteria (1 listed)
- Refusal of consent
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 |
|---|---|---|
| ECMOECMO for circulatory and/or respiratory support | Device | Cardiac Support, Extracorporeal Cardiopulmonary Resuscitation, Pulmonary Support |
Primary outcome
All-cause mortality
Time frame: 30 days
5 secondary outcomes
All-cause mortality
Time frame: 365 days
Rate of successful weaning from ECMO
Time frame: 30 days
ECMO-related complications
Time frame: 30 days
Other complications
Time frame: 30 days
Duration stay at ICU and hospital
Time frame: 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 38987696Yuan Z, Liu Y, Wei G, Wang F, Yao B, Hou X, Xing J. Clinical characteristics of extracorporeal cardiopulmonary resuscitation in China: a multicenter retrospective study. BMC Anesthesiol. 2024 Jul 10;24(1):230. doi: 10.1186/s12871-024-02618-2.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Cardiac Arrest, run by Beijing Anzhen Hospital 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaotong Hou, MD., PhD. (8610 64456631, xt.hou@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). 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 NCT04158479, 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 9 Apr 2024.