Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

A Randomized, Controlled Trial: Hemoperfusion in Extracorporeal Membrane Oxygenation (ECMO) Patients

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.

Study Overview

• Status: Unknown
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Device: hemoperfusion

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, PhD., MD.; Phone Number: 86 18911662932; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
      • Contact: Xiaotong Hou, PhD., MD.; Phone Number: 86 18911662932; Email: xt.hou@ccmu.edu.cn
      • Principal Investigator: Xiaotong Hou, PhD., MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of plasma interleukin (IL)-6 level	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		30 days
ICU length of stay		60 days
Hospital length of stay		60 days
Rate of infection	Any kinds of infection	30 days
Duration on invasive ventilation		60 days
change of other inflammatory factor level	plasma interleukin (IL)-1β、8、10（pg/ml）	3 days
change of other inflammatory factor level	tumor necrosis factor α (TNF-α)（fmol/ml）	3 days
change of other inflammatory factor level	C-reactive protein (CRP)（mg/dl）	3 days
Rate of Multiple organ dysfunction syndrome (MODS)		30 days
Duration on extracorporeal membrane oxygenation (ECMO) support		60 days
Rate of successful weaning from extracorporeal membrane oxygenation (ECMO)	The circulation doesn't deteriorate in 24 hours since weaning from ECMO	30 days
Rate of adverse event		30 days

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Anticipated): November 5, 2020
• Study Completion (Anticipated): July 5, 2021

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: hemoperfusion; inflammatory factor; veno-arterial extracorporeal membrane oxygenation (VA-ECMO)
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: 2018035X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No