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

NCT05309980 | Completed

• 1 other identifier: CHUBX2020RE0273
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiogenic Shock; Short Term Mechanical Circulatory Support; Shock Team

Keywords

Extra Corporeal Membrane Oxygenation; Cardiogenic Shock; Impella; Shock Team; Long Term Mechanical Circulatory Support

Outcome Measures

Primary Outcomes (1)

• Vital status

  Proportion of patients alive

  One year after short term mechanical circulatory support initiation

Secondary Outcomes (19)

• Vital status

  30 days after short term mechanical circulatory support initiation

• Vital status

  3 months after short term mechanical circulatory support initiation

• Vital status

  6 months after short term mechanical circulatory support initiation

• Lenght of stay

  up to Intensive Care Unit discharge, an average of 15 days

• Lenght of stay

  up to one year

Study Arms (2)

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

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

Interventions

standard of care OTHER

retrospective study : standard of care

With Shock Team; Without Shock Team

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexandre Ouattara, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: April 4, 2022
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 15, 2022
• Last Updated: April 10, 2023

Record last verified: 2022-03

Locations

FR (1)