Acute Cardiogenic ShockALLOASSISTNCT03528291
Transient Circulatory Support in Cardiogenic Shock
An observational study of Acute Cardiogenic Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cardiogenic Shock
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2017to 31 Oct 2021
- 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: Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team
Who may be able to join
- Cardiogenic shock :
- Systolic BP<90mmHg despite adequate filling pressure
- Or need of cathecolamines to maintain SBP > 90mmHg
- Signs of right-sided and/or left-sided congestion
- Signs of tissue hypoperfusion : oliguria, cold sweated extremities, mental confusion, dizziness, narrow pulse pressure, blood lactate > 2 mmol/L
- Short-term mechanical circulatory support discussed by the multidisciplinary heart team
Who cannot join
- Post cardiotomy cardiogenic shock
- Refractory cardiac arrest
- Cardiac Arrest with No Flow >3 min and/or non shokable rythm
- Contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation
- Pregnant or brest-feeding women,
- Age < 18 year-old
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Department of Anesthesia-Resuscitation Arnaud de Villeneuve
Montpellier, 34295
Jacob ELIET, M.D, 0467335946, j-eliet@chu-montpellier.fr
About this study
Official title: Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up
The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Some studies described patients with TCS in order to establish mortality predictive scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS decision yet. Therefore, The investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by the heart team.
Read the detailed description
This French multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (TCS) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment.
All patients with cardiogenic shock for whom indication of TCS was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study.
Two groups of patients are defined:
- Patients with cardiogenic shock treated by medical treatement
- Patients with cardiogenic shock treated by TCS (extracorporeal circulatory life support and/or Impella).
The main objective is to compare mortality between the 2 groups. Secondary objectives are ICU follow-up characteristics and quality of life questionnaire at day 180.
Statistical analysis will include a propensity-matched method to compare the groups to avoid confounding factors. The number of necessary subjects (n=240, 120 in each group) was calculated assuming that TCS has a superiority of 20% in comparison with medical treatment in severe cardiogenic shock, with a study power of 80%, and an alpha risk of 5%.
- Conditions
- Acute Cardiogenic Shock
- Keywords
- Human,, adult,, intensive care unit,, cardiogenic shock,, Transient circulatory support,, extra corporeal life support, Impella
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic shock treated with medical treatment | Patients with cardiogenic shock treated only by medical treatment | |
| Cardiogenic shock treated with transient circulatory support | Patients where transient circulatory support was implanted: veno-arterial extracorporeal circulatory life support (ECLS), Impella |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Mortality
Mortality rate in the 2 groups at the time of hospital discharge
Measured: From inclusion day to day 180
Secondary outcomes (9)
Short term mortality rate
Mortality rate at day 28
Measured: From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first
Acute renal failure
Incidence of renal replacement therapy
Measured: From inclusion day to ICU discharge or day 28 whichever came first
Respiratory failure
Days of mechanical ventilation
Measured: From inclusion day to ICU discharge or day 28 whichever came first
Thromboembolic events
Incidence of stroke, peripheral or mesenteric ischemia
Measured: From inclusion day to ICU discharge or day 28 whichever came first
Bleeding events
Incidence of red blood cell transfusion
Measured: From inclusion day to ICU discharge or day 28 whichever came first
ICU stays
Length of stay in ICU (number of days)
Measured: From inclusion day to day 180
Hospital stays
Length of stay in hospital (number of days)
Measured: From inclusion day to day 180
Quality of life score SF 36
Quality of life, evaluated by the Short Form Survey scoring (SF36 score) using the RAND 36-Item Health Survey 1.0, which will be sent by mail at day 180 after inclusion.
The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Measured: From inclusion day to day 180
Long term mortality rate
Mortality rate at day 180
Measured: From inclusion day to day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start12 Jul 2017
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (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 Acute 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob ELIET, M.D, Principal investigator, Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528291
- Sponsor's protocol ID
- 9842
- Acronym
- ALLOASSIST
- Status last verified
- Sep 2021
- First submitted
- 19 Feb 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ughetto A, Eliet J, Nagot N, David H, Bazalgette F, Marin G, Kollen S, Mourad M, Zeroual N, Muller L, Gaudard P, Colson P. Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network. J Heart Lung Transplant. 2024 Jun;43(6):911-919. doi: 10.1016/j.healun.2024.02.009. Epub 2024 Feb 15.
PubMed 38367739
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Relevance of Transient Circulatory Support for Acute Cardiogenic Shock: Patients' Characteristics and Follow-up
- ClinicalTrials.gov ID
- NCT03528291
- Acronym / sponsor ID
- ALLOASSIST / 9842
- Conditions
- Acute Cardiogenic Shock
- Keywords
- Human,, adult,, intensive care unit,, cardiogenic shock,, Transient circulatory support,, extra corporeal life support, Impella
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 17 May 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.
The purpose of this multicenter prospective study is to determine if the decision of transient circulatory support (TCS) in cardiogenic shock is relevant. TCS is a recommended treatment of refractory cardiogenic shock but precise indications are not definitively founded. Some studies described patients with TCS in order to establish mortality predictive scores (ENCOURAGE, SAVE), but no study has assessed the clinical relevance of the TCS decision yet. Therefore, The investigators propose to compare the characteristics and the follow-up of patients in acute cardiogenic shock, once TCS implantation was decided or not by the heart team.
Detailed description
This French multicenter prospective observational study is aimed at determining if the decision of transient circulatory support (TCS) in cardiogenic shock is pertinent, i.e. at least as effective as the medical treatment.
All patients with cardiogenic shock for whom indication of TCS was discussed within the multidisciplinary heart team (cardiologist, intensivist and cardiac surgeon) are consecutively included in the study.
Two groups of patients are defined:
- Patients with cardiogenic shock treated by medical treatement
- Patients with cardiogenic shock treated by TCS (extracorporeal circulatory life support and/or Impella).
The main objective is to compare mortality between the 2 groups. Secondary objectives are ICU follow-up characteristics and quality of life questionnaire at day 180.
Statistical analysis will include a propensity-matched method to compare the groups to avoid confounding factors. The number of necessary subjects (n=240, 120 in each group) was calculated assuming that TCS has a superiority of 20% in comparison with medical treatment in severe cardiogenic shock, with a study power of 80%, and an alpha risk of 5%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic shock treated with medical treatment | – | –Patients with cardiogenic shock treated only by medical treatment |
| Cardiogenic shock treated with transient circulatory support | – | –Patients where transient circulatory support was implanted: veno-arterial extracorporeal circulatory life support (ECLS), Impella |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in cardiogenic shock for whom transient circulatory support was discussed within the multidisciplinary heart team
Key inclusion criteria (6 listed)
- Cardiogenic shock :
- Or need of cathecolamines to maintain SBP > 90mmHg
- Short-term mechanical circulatory support discussed by the multidisciplinary heart team
Key exclusion criteria (6 listed)
- Post cardiotomy cardiogenic shock
- Refractory cardiac arrest
- Cardiac Arrest with No Flow >3 min and/or non shokable rythm
- Contraindication to transient circulatory support because of comorbidities, neurological dysfunction, severe end-organ failure or aortic regurgitation
- Pregnant or brest-feeding women,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital Mortality
Time frame: From inclusion day to day 180
Mortality rate in the 2 groups at the time of hospital discharge
9 secondary outcomes
Short term mortality rate
Time frame: From inclusion day to Intensive Care Unit (ICU) discharge or day 28 whichever came first
Acute renal failure
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Respiratory failure
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Thromboembolic events
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
Bleeding events
Time frame: From inclusion day to ICU discharge or day 28 whichever came first
ICU stays
Time frame: From inclusion day to day 180
Hospital stays
Time frame: From inclusion day to day 180
Quality of life score SF 36
Time frame: From inclusion day to day 180
Long term mortality rate
Time frame: From inclusion day to day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 38367739Ughetto A, Eliet J, Nagot N, David H, Bazalgette F, Marin G, Kollen S, Mourad M, Zeroual N, Muller L, Gaudard P, Colson P. Early temporary mechanical circulatory support for cardiogenic shock: Real-life data from a regional cardiac assistance network. J Heart Lung Transplant. 2024 Jun;43(6):911-919. doi: 10.1016/j.healun.2024.02.009. Epub 2024 Feb 15.
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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.
Jacob ELIET, M.D principal investigator
Montpellier Academic Hospital Department of Anesthesia-Resuscitation Arnaud de Villeneuve
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 Acute Cardiogenic Shock, run by University Hospital, Montpellier 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 6 inclusion and 6 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 23 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacob ELIET, M.D (0467335946, j-eliet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Mortality (time frame: From inclusion day to day 180). 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 NCT03528291, 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 23 Sep 2021; AzTrials last refreshed its copy on 26 Oct 2026.