Cardiogenic ShockCASHMERENCT05309980
Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
An observational study of Cardiogenic Shock and Short Term Mechanical Circulatory Support, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Short Term Mechanical Circulatory Support, Shock Team
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 15 Apr 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with refractory cardiogenic shock treated with short term mechanical circulatory support between January 2007 to April 2019. A two months wash out period following shock team initiation (February and March 2013) has been set.
Who may be able to join
- Diagnosis of cardiogenic shock
- >1 sign of refractory cardiogenic shock : Dobutamine >10µg/kg/mn, epinephrine>0.25µg/kg/mn or Milrinone > 0.5µg/kg/mn ; ScvO2<55% ; pO2/FiO2<100
- No major counter indication to short term mechanical circulatory support : SOFA score > 15, prolonged cardiac arrest, severe chronic disease, direct LVAD implantation or heart transplantation, counter indication for systemic anticoagulation
Who cannot join
- Age < 18years
- Post cardiotomy cardiogenic shock
- Implantation of Impella 2.5 alone
- Implantation of Intra Aortic Balloon Pump alone
Trial locations and contacts
1 site in 1 country.
About this study
In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.
Read the detailed description
Short Term Mechanical Circulatory Support (STMCS) are the last resort therapeutics when refractory cardiogenic shock occurs. Growing technical possibilities like impella make the right choice at the right time challenging. At Bordeaux University Hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in January 2013. From that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. The objective of this study is to perform a before-after comparison between decision of STMCS for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from April 2013 to April 2019.
- Being tested
- standard of care
- Keywords
- Extra Corporeal Membrane Oxygenation, Cardiogenic Shock, Impella, Shock Team, Long Term Mechanical Circulatory Support
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
retrospective study : standard of care
| Study group | Role | What they receive |
|---|---|---|
| Without Shock Team | Before January 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device without involvment of a dedicated shock team Receives: Other: standard of care | |
| With Shock Team | After April 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device following a collegial meeting of a shock team (cardiac surgeon, cardiologist, intensivist) using a common algorythm. Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital status
Proportion of patients alive
Measured: One year after short term mechanical circulatory support initiation
Secondary outcomes (19)
Vital status
proportion of patients alive
Measured: 30 days after short term mechanical circulatory support initiation
Vital status
proportion of patients alive
Measured: 3 months after short term mechanical circulatory support initiation
Vital status
proportion of patients alive
Measured: 6 months after short term mechanical circulatory support initiation
Lenght of stay
Intensive Care Unit length of stay
Measured: up to Intensive Care Unit discharge, an average of 15 days
Lenght of stay
Hospital length of stay
Measured: up to one year
Long term mechanical circulatory support
proportion of patients bridged to long term mechanical circulatory support
Measured: up to intensive care unit discharge, an average of 15 days
Heart transplantation
proportion of patients bridged to heart transplantation
Measured: up to intensive care unit discharge, an average of 15 days
Weaning from short term mechanical circulatory support
proportion of patients sucessfully weaned from short term mechanical circulatory support
Measured: up to seven days from weaning attempt
New renal replacement therapy
proportion of patients needing renal replacement therapy
Measured: up to intensive care unit discharge, an average of 15 days
Limb ischaemia
proportion of patients with limb ischaemia
Measured: through short term mechanical circulatory support weaning, an average of 6 days
Stroke
proportion of patients with stroke
Measured: through short term mechanical circulatory support weaning, an average of 6 days
Short term mechanical circulatory support duration
Short term mechanical circulatory support duration
Measured: through short term mechanical circulatory support weaning, an average of 6 days
Severe haemorrage
proportion of patients with severe haemorrage (massive haemorrhage according to SFAR or use of Novoseven or rescue surgery for bleeding)
Measured: through short term mechanical circulatory support weaning, an average of 6 days
Extra Corporeal Membrane Oxygenation circuit clotting
proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured
Measured: through short term mechanical circulatory support weaning, an average of 6 days
Sepsis
proportion of patients in which sepsis occured
Measured: up to intensive care unit discharge, an average of 15 days
Vital status
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
Measured: One year after short term mechanical circulatory support initiation
Vital status
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
Measured: 30 days after short term mechanical circulatory support initiation
Vital status
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
Measured: 3 months after short term mechanical circulatory support initiation
Vital status
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
Measured: 6 months after short term mechanical circulatory support initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion15 Apr 2022
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 University Hospital, BordeauxThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre OUATTARA, University Hospital, Bordeaux
- Investigators
- Alexandre Ouattara, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309980
- Sponsor's protocol ID
- CHUBX2020RE0273
- Acronym
- CASHMERE
- Status last verified
- Mar 2022
- First submitted
- 8 Dec 2021
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
- ClinicalTrials.gov ID
- NCT05309980
- Acronym / sponsor ID
- CASHMERE / CHUBX2020RE0273
- Keywords
- Extra Corporeal Membrane Oxygenation, Cardiogenic Shock, Impella, Shock Team, Long Term Mechanical Circulatory Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 4 Apr 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.
In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory support.
Detailed description
Short Term Mechanical Circulatory Support (STMCS) are the last resort therapeutics when refractory cardiogenic shock occurs. Growing technical possibilities like impella make the right choice at the right time challenging. At Bordeaux University Hospital, we have gathered the main protagonists which are the surgeon, the interventional cardiologist,and the intensivist as a shock team in January 2013. From that time, diagnosis of refractory cardiogenic shock triggers a multidisciplinary meeting driven by a common algorithm. The objective of this study is to perform a before-after comparison between decision of STMCS for refractory cardiogenic shock without shock team from january 2007 to january 2013 and after implementation of the shock team from April 2013 to April 2019.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without Shock Team | – | Other: standard of careBefore January 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device without involvment of a dedicated shock team |
| With Shock Team | – | Other: standard of careAfter April 2013, patients with refractory cardiogenic shock were implanted with short term mechanical circulatory device following a collegial meeting of a shock team (cardiac surgeon, cardiologist, intensivist) using a common algorythm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with refractory cardiogenic shock treated with short term mechanical circulatory support between January 2007 to April 2019. A two months wash out period following shock team initiation (February and March 2013) has been set.
Key inclusion criteria (3 listed)
- Diagnosis of cardiogenic shock
- >1 sign of refractory cardiogenic shock : Dobutamine >10µg/kg/mn, epinephrine>0.25µg/kg/mn or Milrinone > 0.5µg/kg/mn ; ScvO2<55% ; pO2/FiO2<100
- No major counter indication to short term mechanical circulatory support : SOFA score > 15, prolonged cardiac arrest, severe chronic disease, direct LVAD implantation or heart transplantation, counter indication for systemic anticoagulation
Key exclusion criteria (4 listed)
- Age < 18years
- Post cardiotomy cardiogenic shock
- Implantation of Impella 2.5 alone
- Implantation of Intra Aortic Balloon Pump alone
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 |
|---|---|---|
| standard of careretrospective study : standard of care | Other | With Shock Team, Without Shock Team |
Primary outcome
Vital status
Time frame: One year after short term mechanical circulatory support initiation
Proportion of patients alive
19 secondary outcomes
Vital status
Time frame: 30 days after short term mechanical circulatory support initiation
Vital status
Time frame: 3 months after short term mechanical circulatory support initiation
Vital status
Time frame: 6 months after short term mechanical circulatory support initiation
Lenght of stay
Time frame: up to Intensive Care Unit discharge, an average of 15 days
Lenght of stay
Time frame: up to one year
Long term mechanical circulatory support
Time frame: up to intensive care unit discharge, an average of 15 days
Heart transplantation
Time frame: up to intensive care unit discharge, an average of 15 days
Weaning from short term mechanical circulatory support
Time frame: up to seven days from weaning attempt
New renal replacement therapy
Time frame: up to intensive care unit discharge, an average of 15 days
Limb ischaemia
Time frame: through short term mechanical circulatory support weaning, an average of 6 days
Stroke
Time frame: through short term mechanical circulatory support weaning, an average of 6 days
Short term mechanical circulatory support duration
Time frame: through short term mechanical circulatory support weaning, an average of 6 days
Severe haemorrage
Time frame: through short term mechanical circulatory support weaning, an average of 6 days
Extra Corporeal Membrane Oxygenation circuit clotting
Time frame: through short term mechanical circulatory support weaning, an average of 6 days
Sepsis
Time frame: up to intensive care unit discharge, an average of 15 days
Vital status
Time frame: One year after short term mechanical circulatory support initiation
Vital status
Time frame: 30 days after short term mechanical circulatory support initiation
Vital status
Time frame: 3 months after short term mechanical circulatory support initiation
Vital status
Time frame: 6 months after short term mechanical circulatory support initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Alexandre Ouattara, MD, PhD principal investigator
University Hospital, Bordeaux
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 Short Term Mechanical Circulatory Support, run by University Hospital, Bordeaux at 1 site in France.
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: finished, as of the sponsor's last update on 10 Apr 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital status (time frame: One year after short term mechanical circulatory support initiation). 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 10 Apr 2023.