ECLS Versus IMPELLA™ as Bridge to LVAD (ECI-BLAD)

Cardiogenic Shock Clinical Trial

— ECI-BLAD  

Official title:

ExtraCorporeal Life Support (ECLS) Versus IMPELLA™ Pump as Bridge to Left Ventricular Assist Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04480151
• Other study ID #: CHUBX 2020/37
• Status: Completed
• Start date: January 20, 2021
• Est. completion date: April 21, 2021

Study information

• Verified date: July 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this retrospective observational multicenter study the authors tested the hypothesis that the use of IMPELLA™ pump as bridge to bridge, by giving the opportunity of active rehabilitation, should improve patient's outcomes after the implantation of Left Ventricular Assist Device (LVAD).

Description:

End stage heart failure patients admitted in Intensive Care Unit (ICU) for refractory cardiogenic shock requiring short-term mechanical circulatory support as a bridge to a long-term LVAD might benefit from early mobilization and rehabilitation with IMPELLA™ inserted via the axillary artery. The aim of this study is to compare the early rehabilitation and outcomes after LVAD implantation between patients previously treated by IMPELLA™ or ExtraCorporeal Life Support (ECLS)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients supported with IMPELLA™ or ECLS for refractory cardiogenic shock as a bridge to long duration LVAD

Exclusion Criteria:

• Patient refusing to give access to their medical chart

• Guardianship and curactorship

• Deprived of liberty

• short term mechanical circulatory system weaned before LVAD implantation

Related Conditions & MeSH terms

• Cardiogenic Shock
• End-stage Heart Failure
• Heart Failure
• Shock, Cardiogenic

Intervention

Other:
• standard of care
retrospective study: standard of care

Locations

Country	Name	City	State
France	CHU de Dijon-Bourgoigne	Dijon
France	CHU de Montpellier	Montpellier
France	CHU de Bordeaux	Pessac
France	CHU de Rennes	Rennes
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8 at 30 days after the LVAD implantation	Proportion of patients alive in the surgery ward, not requiring intravenous access and walking (John Hopkins highest level of mobility (JH-HLM) scale = 8) at 30 days after the LVAD implantation	Day 30 after Left Ventricular Assist Device (LVAD) implantation
Secondary	Complication and rehabilitation under Short-term Mechanical Circulatory support	Duration of support, bleeding, hemolysis, surgical re-exploration, thombus, renal replacement therapy, blood products transfusion, stroke, tracheal extubation, mobilization (chair, walking and ergometry)	The day of Left Ventricular Assist Device (LVAD) implantation
Secondary	Organ dysfunction before LVAD implantation	Need for mechanical ventilation, Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day before LVAD implantation
Secondary	complication Under LVAD	bleeding, right ventricular dysfunction, vasoplegia	The day of Intensive Care Unit (ICU) discharge
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day of Short Term Mechanical Circulatory Support (STMCS) implantation
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	The day of LVAD implantation
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 1 post LVAD implantation
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 3 post LVAD implantation
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 5 post LVAD implantation
Secondary	SOFA score	Organ dysfunction assessed by Sequential Organ Failure Assessment (SOFA) score [0= best outcome to 24 = worst outcome]	Day 7 post LVAD implantation
Secondary	Vital status	mortality after LVAD implantation	1 month after LVAD implantation
Secondary	Vital status	mortality after LVAD implantation	3 months after LVAD implantation
Secondary	Vital status	mortality after LVAD implantation	6 months after LVAD implantation
Secondary	length of stay	Intensive Care Unit length of stay	up to Intensive Care Unit (ICU) discharge (not more than 6 months after LVAD implantation)
Secondary	length of stay	hospital length of stay	up to hospital discharge (not more than 6 months after LVAD implantation)