Back to resultsHemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Primary Purpose
Cardiogenic Shock
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hemoperfusion
Sponsored by
About this trial
This is an interventional treatment trial for Cardiogenic Shock focused on measuring veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 75 years.
- Admission to ICU.
- Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
- ECMO will supply cardiopulmonary support to the patient
- The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
Exclusion Criteria:
- Refusal of consent.
- Active hemorrhage or thrombocytopenic purpura
- BMI≥40
- Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
- Infection
Sites / Locations
- Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
hemoperfusion
standard care
Arm Description
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced.
Outcomes
Primary Outcome Measures
change of plasma interleukin (IL)-6 level
Secondary Outcome Measures
change of other inflammatory factor level
plasma interleukin (IL)-1β、8、10（pg/ml）
change of other inflammatory factor level
tumor necrosis factor α (TNF-α)（fmol/ml）
change of other inflammatory factor level
C-reactive protein (CRP)（mg/dl）
All-cause mortality
Rate of Multiple organ dysfunction syndrome (MODS)
Rate of infection
Any kinds of infection
Duration on extracorporeal membrane oxygenation (ECMO) support
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)
The circulation doesn't deteriorate in 24 hours since weaning from ECMO
Duration on invasive ventilation
ICU length of stay
Hospital length of stay
Rate of adverse event
Full Information
NCT ID
NCT03729765
First Posted
October 30, 2018
Last Updated
January 25, 2019
Sponsor
Beijing Anzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03729765
Brief Title
Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Official Title
A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
November 5, 2020 (Anticipated)
Study Completion Date
July 5, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Extracorporeal membrane oxygenation (ECMO) is a temporary mechanical circulatory support device for cardiogenic shock (CS) patients. During extracorporeal membrane oxygenation (ECMO) support, the inflammatory response is intense and complex. It may cause infection, cell damage, organ dysfunction and even death. Hemoperfusion can adsorb inflammatory factors and reduce the inflammatory reaction. CS patients who are likely to receive veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support will be enrolled and randomized with a 1:1 allocation to a simultaneous hemoperfusion arm vs. standard care arm.
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
The primary outcome is the change of plasma interleukin (IL)-6 level after hemoperfusion is commenced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiogenic Shock
Keywords
veno-arterial extracorporeal membrane oxygenation (VA-ECMO), hemoperfusion, inflammatory factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hemoperfusion
Arm Type
Experimental
Arm Description
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
Arm Title
standard care
Arm Type
No Intervention
Arm Description
The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced.
Intervention Type
Device
Intervention Name(s)
hemoperfusion
Intervention Description
The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
Primary Outcome Measure Information:
Title
change of plasma interleukin (IL)-6 level
Time Frame
3 days
Secondary Outcome Measure Information:
Title
change of other inflammatory factor level
Description
plasma interleukin (IL)-1β、8、10（pg/ml）
Time Frame
3 days
Title
change of other inflammatory factor level
Description
tumor necrosis factor α (TNF-α)（fmol/ml）
Time Frame
3 days
Title
change of other inflammatory factor level
Description
C-reactive protein (CRP)（mg/dl）
Time Frame
3 days
Title
All-cause mortality
Time Frame
30 days
Title
Rate of Multiple organ dysfunction syndrome (MODS)
Time Frame
30 days
Title
Rate of infection
Description
Any kinds of infection
Time Frame
30 days
Title
Duration on extracorporeal membrane oxygenation (ECMO) support
Time Frame
60 days
Title
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)
Description
The circulation doesn't deteriorate in 24 hours since weaning from ECMO
Time Frame
30 days
Title
Duration on invasive ventilation
Time Frame
60 days
Title
ICU length of stay
Time Frame
60 days
Title
Hospital length of stay
Time Frame
60 days
Title
Rate of adverse event
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 75 years.
Admission to ICU.
Criteria for the diagnosis of CS as follows: (1) systolic blood pressure less than 90 mmHg for 30 min, a mean arterial pressure less than 65 mmHg for 30 min, or vasopressors required to achieve a blood pressure ≥ 90 mmHg; (2) pulmonary congestion or elevated left-ventricular filling pressures; and (3) signs of impaired organ perfusion with at least one of the following criteria: (a) altered mental status; (b) cold, clammy skin; (c) oliguria; and (d) increased serum lactate.
ECMO will supply cardiopulmonary support to the patient
The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.
Exclusion Criteria:
Refusal of consent.
Active hemorrhage or thrombocytopenic purpura
BMI≥40
Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
Infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaotong Hou, PhD., Md.
Phone
86 18911662932
Email
xt.hou@ccmu.edu.cn
Facility Information:
Facility Name
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaotong Hou, PhD., MD.
Phone
86 18911662932
Email
xt.hou@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaotong Hou, PhD., MD.
12. IPD Sharing Statement
Learn more about this trial
Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
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