Cardiogenic ShockVREM-CSNCT06862700
Effect of Reduced Vasopressors on Mortality in ECMO-supported Cardiogenic Shock Patients
An observational study of Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Xiaotong Hou at 1 site in China.
Trial summary
The goal of this observational study is to learn about the association between vasopressor exposure levels and outcomes in adults with cardiogenic shock receiving VA-ECMO. The main question it aims to answer is: Does reduced exposure to vasopressors lower the 30-day mortality in patients with cardiogenic shock when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Vasopressors
- What is being tested?
- Vasopressor Exposure Levels
- How many people
- 534 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2025to 1 Jan 2028
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At participating centers, adult patients with cardiogenic shock require venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, meeting specific hemodynamic and end-organ dysfunction criteria.
Who may be able to join
- Adults (≥18 years) with cardiogenic shock requiring VA-ECMO support.
- First-time ECMO initiation.
- Venoarterial ECMO (VA-ECMO) as the initial mode.
Who cannot join
- Age <18 years.
- Severe pulmonary hypertension.
- Vasopressor use for non-shock indications (e.g., bleeding, post-cardiopulmonary bypass vasoplegia).
- Severe missing data.
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
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
Zhongtao Du, MD, 86-18610846901, zhongtaodu@126.com
Xiaotong Hou, MD
About this study
Official title: Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study
The goal of this observational study is to learn about the association between vasopressor exposure levels and outcomes in adults with cardiogenic shock receiving VA-ECMO. The main question it aims to answer is:
Does reduced exposure to vasopressors lower the 30-day mortality in patients with cardiogenic shock when receiving ECMO support? Participants who are receiving ECMO support for cardiogenic shock as part of their regular medical care will have their data collected, including information about their vasopressor use and mortality outcomes, over the course of the study.
Read the detailed description
The study will enroll 534 patients from multiple centers who require VA-ECMO for cardiogenic shock. Patients will be stratified into two groups based on their average Vasoactive-Inotropic Score (VIS) from 12 hours post-ECMO initiation to weaning: a high-dose group (VIS >10) and a low-dose group (VIS ≤10). The primary outcome is 30-day all-cause mortality. Secondary outcomes include hospital survival rate, duration of mechanical ventilation, ICU and hospital length of stay, and ECMO-related complications. Hemodynamic parameters and laboratory biomarkers will be monitored. The study aims to identify optimal hemodynamic management strategies, including ECMO flow rates, blood pressure targets, and vasopressor dosing, to improve patient outcomes.
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Vasopressors, Hemodynamic Management, Critical Care, Heart Failure
- Being tested
- Vasopressor Exposure Levels
- Medical subject headings
- Shock, Cardiogenic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressor Exposure LevelsOther
Also called Vasoactive-Inotropic Score (VIS)
This is an observational study with no active intervention. The study evaluates the association between natural variations in vasopressor exposure levels (measured by Vasoactive-Inotropic Score, VIS) and clinical outcomes in patients receiving VA-ECMO for cardiogenic shock.
| Study group | Role | What they receive |
|---|---|---|
| High VIS Group | High VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) >10 from 12 hours post-ECMO initiation to weaning. Receives: Other: Vasopressor Exposure Levels | |
| Low VIS Group | Low VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) ≤10 from 12 hours post-ECMO initiation to weaning. Receives: Other: Vasopressor Exposure Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-Day All-Cause Mortality
The proportion of patients who die from any cause within 30 days following ECMO initiation.
Measured: From ECMO initiation through hospital discharge (assessed up to 6 months).
Secondary outcomes (2)
In-Hospital Survival Rate
The proportion of patients who survive to hospital discharge.
Measured: From ECMO initiation through hospital discharge (assessed up to 6 months).
ECMO-Related Complications
The incidence of ECMO-related complications, including bleeding, thrombosis, infection, and mechanical failures.
Measured: From ECMO initiation through hospital discharge (assessed up to 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start26 Feb 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (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.
- 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
- 534 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Xiaotong Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaotong Hou, Beijing Anzhen Hospital
- Investigators
- Zhongtao Du, MD, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862700
- Sponsor's protocol ID
- 2025038x
- Acronym
- VREM-CS
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Vasopressor Exposure Levels and 30-Day Mortality in Patients Receiving ECMO Support for Cardiogenic Shock: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06862700
- Acronym / sponsor ID
- VREM-CS / 2025038x
- Conditions
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation, Vasopressors, Hemodynamic Management, Critical Care, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 534 participants (estimated)
- Lead sponsor
- Xiaotong HouUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 6 Mar 2025 (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 goal of this observational study is to learn about the association between vasopressor exposure levels and outcomes in adults with cardiogenic shock receiving VA-ECMO. The main question it aims to answer is:
Does reduced exposure to vasopressors lower the 30-day mortality in patients with cardiogenic shock when receiving ECMO support? Participants who are receiving ECMO support for cardiogenic shock as part of their regular medical care will have their data collected, including information about their vasopressor use and mortality outcomes, over the course of the study.
Detailed description
The study will enroll 534 patients from multiple centers who require VA-ECMO for cardiogenic shock. Patients will be stratified into two groups based on their average Vasoactive-Inotropic Score (VIS) from 12 hours post-ECMO initiation to weaning: a high-dose group (VIS >10) and a low-dose group (VIS ≤10). The primary outcome is 30-day all-cause mortality. Secondary outcomes include hospital survival rate, duration of mechanical ventilation, ICU and hospital length of stay, and ECMO-related complications. Hemodynamic parameters and laboratory biomarkers will be monitored. The study aims to identify optimal hemodynamic management strategies, including ECMO flow rates, blood pressure targets, and vasopressor dosing, to improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High VIS Group | – | Other: Vasopressor Exposure LevelsHigh VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) >10 from 12 hours post-ECMO initiation to weaning. |
| Low VIS Group | – | Other: Vasopressor Exposure LevelsLow VIS Group: Patients with an average Vasoactive-Inotropic Score (VIS) ≤10 from 12 hours post-ECMO initiation to weaning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At participating centers, adult patients with cardiogenic shock require venoarterial extracorporeal membrane oxygenation (VA-ECMO) support, meeting specific hemodynamic and end-organ dysfunction criteria.
Key inclusion criteria (3 listed)
- Adults (≥18 years) with cardiogenic shock requiring VA-ECMO support.
- First-time ECMO initiation.
- Venoarterial ECMO (VA-ECMO) as the initial mode.
Key exclusion criteria (4 listed)
- Age <18 years.
- Severe pulmonary hypertension.
- Vasopressor use for non-shock indications (e.g., bleeding, post-cardiopulmonary bypass vasoplegia).
- Severe missing data.
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 |
|---|---|---|
| Vasopressor Exposure LevelsAlso: Vasoactive-Inotropic Score (VIS)This is an observational study with no active intervention. The study evaluates the association between natural variations in vasopressor exposure levels (measured by Vasoactive-Inotropic Score, VIS) and clinical outcomes in patients receiving VA-ECMO for cardiogenic shock. | Other | High VIS Group, Low VIS Group |
Primary outcome
30-Day All-Cause Mortality
Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).
The proportion of patients who die from any cause within 30 days following ECMO initiation.
2 secondary outcomes
In-Hospital Survival Rate
Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).
ECMO-Related Complications
Time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).
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 6 Mar 2025.
- 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.
Zhongtao Du, MD 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?
An observational study of Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Xiaotong Hou 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 3 inclusion and 4 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 6 Mar 2025. 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 (010-64456631, 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?
30-Day All-Cause Mortality (time frame: From ECMO initiation through hospital discharge (assessed up to 6 months).). 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 6 Mar 2025.