Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team (CASHMERE)

April 7, 2023 updated by: Alexandre OUATTARA, University Hospital, Bordeaux
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Pessac, France, 33604
        • Bordeaux University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age < 18years
  • Post cardiotomy cardiogenic shock
  • Implantation of Impella 2.5 alone
  • Implantation of Intra Aortic Balloon Pump alone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: standard of care
retrospective study : 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.
Other: standard of care
retrospective study : standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: One year after short term mechanical circulatory support initiation
Proportion of patients alive
One year after short term mechanical circulatory support initiation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vital status
Time Frame: 30 days after short term mechanical circulatory support initiation
proportion of patients alive
30 days after short term mechanical circulatory support initiation
Vital status
Time Frame: 3 months after short term mechanical circulatory support initiation
proportion of patients alive
3 months after short term mechanical circulatory support initiation
Vital status
Time Frame: 6 months after short term mechanical circulatory support initiation
proportion of patients alive
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
Intensive Care Unit length of stay
up to Intensive Care Unit discharge, an average of 15 days
Lenght of stay
Time Frame: up to one year
Hospital length of stay
up to one year
Long term mechanical circulatory support
Time Frame: up to intensive care unit discharge, an average of 15 days
proportion of patients bridged to long term mechanical circulatory support
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
proportion of patients bridged to heart transplantation
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
proportion of patients sucessfully weaned from short term mechanical circulatory support
up to seven days from weaning attempt
New renal replacement therapy
Time Frame: up to intensive care unit discharge, an average of 15 days
proportion of patients needing renal replacement therapy
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
proportion of patients with limb ischaemia
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
proportion of patients with stroke
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
Short term mechanical circulatory support duration
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
proportion of patients with severe haemorrage (massive haemorrhage according to SFAR or use of Novoseven or rescue surgery for bleeding)
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
proportion of patients in which Extra Corporeal Membrane Oxygenation circuit clotting occured
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
proportion of patients in which sepsis occured
up to intensive care unit discharge, an average of 15 days
Vital status
Time Frame: One year after short term mechanical circulatory support initiation
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
One year after short term mechanical circulatory support initiation
Vital status
Time Frame: 30 days after short term mechanical circulatory support initiation
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
30 days after short term mechanical circulatory support initiation
Vital status
Time Frame: 3 months after short term mechanical circulatory support initiation
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
3 months after short term mechanical circulatory support initiation
Vital status
Time Frame: 6 months after short term mechanical circulatory support initiation
proportion of patients alive when bridged to long term mechanical circulatory device or when transplanted
6 months after short term mechanical circulatory support initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX2020RE0273

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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