Cardiogenic ShockNCT03729765
Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
A study testing hemoperfusion in people with Cardiogenic Shock, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- hemoperfusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2018to 31 Dec 2023
- 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 ≥ 18 and ≤ 75 years.
- Admission to ICU.
- Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- ECMO will supply cardiopulmonary support to the patient
- The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
Who cannot join
- Refusal of consent.
- Active hemorrhage or thrombocytopenic purpura
- BMI≥40
- Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
- Infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Dannuo Han, 13720055429, handannuo@163.com
About this study
Official title: A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm.
- The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
- The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
- Conditions
- Cardiogenic Shock
- Being tested
- hemoperfusion
- Keywords
- veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemoperfusionDevice
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| hemoperfusion | Experimental | The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours. Receives: Device: hemoperfusion |
| standard care | No intervention | The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of plasma interleukin (IL)-6 level
Measured: 3 days
Secondary outcomes (12)
change of other inflammatory factor level
plasma interleukin (IL)-1β、8、10（pg/ml）
Measured: 3 days
change of other inflammatory factor level
tumor necrosis factor α (TNF-α)（fmol/ml）
Measured: 3 days
change of other inflammatory factor level
C-reactive protein (CRP)（mg/dl）
Measured: 3 days
All-cause mortality
Measured: 30 days
Rate of Multiple organ dysfunction syndrome (MODS)
Measured: 30 days
Rate of infection
Any kinds of infection
Measured: 30 days
Duration on extracorporeal membrane oxygenation (ECMO) support
Measured: 60 days
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)
The circulation doesn't deteriorate in 24 hours since weaning from ECMO
Measured: 30 days
Duration on invasive ventilation
Measured: 60 days
ICU length of stay
Measured: 60 days
Hospital length of stay
Measured: 60 days
Rate of adverse event
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start19 Oct 2018
- Primary completion31 Jan 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Dannuo Han, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729765
- Sponsor's protocol ID
- 2018035X
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
- ClinicalTrials.gov ID
- NCT03729765
- Acronym / sponsor ID
- 2018035X
- Conditions
- Cardiogenic Shock
- Keywords
- veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 19 Oct 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Nov 2018 (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 membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm.
- The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
- The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemoperfusion | Experimental | Device: hemoperfusionThe patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours. |
| standard care | No intervention | –The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 and ≤ 75 years.
- Admission to ICU.
- Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- ECMO will supply cardiopulmonary support to the patient
- The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
Key exclusion criteria (5 listed)
- Refusal of consent.
- Active hemorrhage or thrombocytopenic purpura
- BMI≥40
- Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
- Infection
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 |
|---|---|---|
| hemoperfusionThe patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours. | Device | hemoperfusion |
Primary outcome
change of plasma interleukin (IL)-6 level
Time frame: 3 days
12 secondary outcomes
change of other inflammatory factor level
Time frame: 3 days
change of other inflammatory factor level
Time frame: 3 days
change of other inflammatory factor level
Time frame: 3 days
All-cause mortality
Time frame: 30 days
Rate of Multiple organ dysfunction syndrome (MODS)
Time frame: 30 days
Rate of infection
Time frame: 30 days
Duration on extracorporeal membrane oxygenation (ECMO) support
Time frame: 60 days
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)
Time frame: 30 days
Duration on invasive ventilation
Time frame: 60 days
ICU length of stay
Time frame: 60 days
Hospital length of stay
Time frame: 60 days
Rate of adverse event
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
Dannuo Han study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemoperfusion in people with Cardiogenic Shock, 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 5 inclusion and 5 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 24 Nov 2023. 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 Xiaotong Hou, PhD., Md. (86 18911662932, 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?
change of plasma interleukin (IL)-6 level (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2023.