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The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO (CLEAN ECMO)

Primary Purpose

Cardiogenic Shock

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
oXiris membrane
Blood tests
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiogenic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with more than 18 years old 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. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3. Written informed consent from patient or legal surrogates Exclusion Criteria: Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. Shock with unwitnessed cardiac arrest outside the hospital Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) Suspicious of brain death Those who refused active treatment body weight under 30 kg Heparin allergy

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Oxiris for 24 h

Usual care

Outcomes

Primary Outcome Measures

Change in VIS day 0 and day 2
VIS, Vasoactive Inotropic Score; dopamine dose (mg/kg/min) + dobutamine dose (mg/kg/min) + 100 x epinephrine dose (mg/kg/ min) + 10 x milrinone dose (mg/kg/min) + 10,000 x vasopressin dose (unit/kg/min) + 100 x norepinephrine dose (mg/kg/min); A high score indicates the use of a high-dose vasoactive agent.

Secondary Outcome Measures

Full Information

First Posted
November 28, 2022
Last Updated
February 28, 2023
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05642273
Brief Title
The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO
Acronym
CLEAN ECMO
Official Title
The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Oxiris for 24 h
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Device
Intervention Name(s)
oXiris membrane
Intervention Description
oXiris membrane for 24h
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood tests
Intervention Description
Blood tests just after randomization (H0) and at H24, H48 and 7 days
Primary Outcome Measure Information:
Title
Change in VIS day 0 and day 2
Description
VIS, Vasoactive Inotropic Score; dopamine dose (mg/kg/min) + dobutamine dose (mg/kg/min) + 100 x epinephrine dose (mg/kg/ min) + 10 x milrinone dose (mg/kg/min) + 10,000 x vasopressin dose (unit/kg/min) + 100 x norepinephrine dose (mg/kg/min); A high score indicates the use of a high-dose vasoactive agent.
Time Frame
day 0 and day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with more than 18 years old 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. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3. Written informed consent from patient or legal surrogates Exclusion Criteria: Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. Shock with unwitnessed cardiac arrest outside the hospital Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) Suspicious of brain death Those who refused active treatment body weight under 30 kg Heparin allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ryoung-Eun Ko, MD, PhD
Phone
82-02-3410-6399
Email
koryoungeun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Hoon Yang, MD, PhD
Organizational Affiliation
Department of Critical Care Medicine, Samsung Medical Center, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong Hoon Yang, MD, PhD
Phone
82-2-3410-3419
Email
jhysmc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO

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