ECMOsorb Trial - Impact of a VA-ECMO in Combination with CytoSorb in Critically Ill Patients with Cardiogenic Shock

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2025-12-31

Brief Summary

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In the ECMOsorb study the impact of a veno-arterial -ECMO in combination with an extracorporeal cytokine hemadsorption system in critically ill patients with cardiogenic shock is to be examined

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Detailed Description

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The prospective, interventional, randomised controlled and blinded ECMOsorb study investigates in critically ill patinets with cardiogenic shock and with veno-arterial ECMO (VA-ECMO) treatment the impact of an extracorporeal cytokin hemadsorption system on hemodynamics, defined by the Inotropic Score 72 hours after initiation of the adsorber (intervention) or normal ECMO tube (control) in the VA-ECMO.

Conditions

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Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, randomized, controlled, blinded, monocenter trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

masking by using a "black-box"; the control group only receives a regular ECMO tube

Study Groups

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VA-ECMO and CytoSorb

standard ICU care WITH CytoSorb

Group Type EXPERIMENTAL

CytoSorb

Intervention Type DEVICE

An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit

VA-ECMO only

standard ICU care WITHOUT CytoSorb

Group Type PLACEBO_COMPARATOR

VA-ECMO only

Intervention Type OTHER

only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added

Interventions

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CytoSorb

An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit

Intervention Type DEVICE

VA-ECMO only

only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added

Intervention Type OTHER

Other Intervention Names

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Standard ICU care (with VA-ECMO) AND CytoSorb Adsorber Standard ICU care (with VA-ECMO)

Eligibility Criteria

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Inclusion Criteria

* Cardiogenic shock of any cause and indication for VA-ECMO
* Age between 18 and 80
* Signed informed consent

Exclusion Criteria

* Current participation in another interventional trial
* Pregnancy
* Current immunosuppressive or immunomodulatory therapy
* Contraindications to VA-ECMO implantation.
* Patients with pre - existing sepsis (raised CPR, positive PCT, leukozytosis, fever, positive blood cultures).
* Shock duration\> 12 h before evaluation.
* Severe PVD (peripheral vessel disease) making ECMO-implantation impossible.
* Aortic valve insufficiency / stenosis at least II °.
* Age \> 80 years.
* CNS disease with fixed, dilated pupils (not drug-induced).
* Severe concomitant disease with limited life expectancy \<6 months.
* CPR\> 60min.
* Shock due to other reasons
* HIT positive (Heparin induced thrombocytopenia)
* Very low platelet counts (\< 20,000/µl)
* Body weight less than 45 kg

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No