The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2024-01-08

Brief Summary

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Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.

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Detailed Description

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Conditions

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Cardiogenic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Oxiris for 24 h

Group Type EXPERIMENTAL

oXiris membrane

Intervention Type DEVICE

oXiris membrane for 24h

Blood tests

Intervention Type DIAGNOSTIC_TEST

Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days

Control

Usual care

Group Type ACTIVE_COMPARATOR

Blood tests

Intervention Type DIAGNOSTIC_TEST

Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days

Interventions

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oXiris membrane

oXiris membrane for 24h

Intervention Type DEVICE

Blood tests

Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Patients with more than 18 years old
2. CS is defined as the presence of the following:

2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.

2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.

2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
3. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3.
4. Written informed consent from patient or legal surrogates

Exclusion Criteria

1. Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure.
2. Shock with unwitnessed cardiac arrest outside the hospital
3. Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
4. Suspicious of brain death
5. Those who refused active treatment
6. Body weight under 30 kg
7. Heparin allergy
8. Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No