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Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

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ClinicalTrials.gov Identifier: NCT03729765
Recruitment Status : Unknown
Verified January 2019 by Xiaotong Hou, Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : November 5, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaotong Hou, Beijing Anzhen Hospital

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.

  1. The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
  2. 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.


Condition or disease Intervention/treatment Phase
Cardiogenic Shock Device: hemoperfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients
Actual Study Start Date : October 19, 2018
Estimated Primary Completion Date : November 5, 2020
Estimated Study Completion Date : July 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: hemoperfusion
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.
Device: hemoperfusion
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.

No Intervention: standard care
The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced.



Primary Outcome Measures :
  1. change of plasma interleukin (IL)-6 level [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. change of other inflammatory factor level [ Time Frame: 3 days ]
    plasma interleukin (IL)-1β、8、10(pg/ml)

  2. change of other inflammatory factor level [ Time Frame: 3 days ]
    tumor necrosis factor α (TNF-α)(fmol/ml)

  3. change of other inflammatory factor level [ Time Frame: 3 days ]
    C-reactive protein (CRP)(mg/dl)

  4. All-cause mortality [ Time Frame: 30 days ]
  5. Rate of Multiple organ dysfunction syndrome (MODS) [ Time Frame: 30 days ]
  6. Rate of infection [ Time Frame: 30 days ]
    Any kinds of infection

  7. Duration on extracorporeal membrane oxygenation (ECMO) support [ Time Frame: 60 days ]
  8. Rate of successful weaning from extracorporeal membrane oxygenation (ECMO) [ Time Frame: 30 days ]
    The circulation doesn't deteriorate in 24 hours since weaning from ECMO

  9. Duration on invasive ventilation [ Time Frame: 60 days ]
  10. ICU length of stay [ Time Frame: 60 days ]
  11. Hospital length of stay [ Time Frame: 60 days ]
  12. Rate of adverse event [ Time Frame: 30 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 75 years.
  2. Admission to ICU.
  3. 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.
  4. ECMO will supply cardiopulmonary support to the patient
  5. The patients will be enrolled and randomized when ECMO is commenced less than 24 hours.

Exclusion Criteria:

  1. Refusal of consent.
  2. Active hemorrhage or thrombocytopenic purpura
  3. BMI≥40
  4. Received ECMO bridging to a long-term ventricle assist device or heart transplantation.
  5. Infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729765


Contacts
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Contact: Xiaotong Hou, PhD., Md. 86 18911662932 xt.hou@ccmu.edu.cn

Locations
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China, Beijing
Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100029
Contact: Xiaotong Hou, PhD., MD.    86 18911662932    xt.hou@ccmu.edu.cn   
Principal Investigator: Xiaotong Hou, PhD., MD.         
Sponsors and Collaborators
Beijing Anzhen Hospital
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Responsible Party: Xiaotong Hou, Director of Center for Cardiac Intensive Care, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT03729765    
Other Study ID Numbers: 2018035X
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaotong Hou, Beijing Anzhen Hospital:
veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
hemoperfusion
inflammatory factor
Additional relevant MeSH terms:
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Shock, Cardiogenic
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Shock
Pathologic Processes