NCT03729765

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. 1.The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.
  2. 2.The patients in the standard care arm will not receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 19, 2018

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

October 30, 2018

Last Update Submit

November 22, 2023

Conditions

Cardiogenic Shock

Keywords

veno-arterial extracorporeal membrane oxygenation (VA-ECMO)hemoperfusioninflammatory factor

Outcome Measures

Primary Outcomes (1)

  • change of plasma interleukin (IL)-6 level

    3 days

Secondary Outcomes (12)

  • change of other inflammatory factor level

    3 days

  • change of other inflammatory factor level

    3 days

  • change of other inflammatory factor level

    3 days

  • All-cause mortality

    30 days

  • Rate of Multiple organ dysfunction syndrome (MODS)

    30 days

  • +7 more secondary outcomes

Study Arms (2)

hemoperfusion

EXPERIMENTAL

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

standard care

NO INTERVENTION

The patients in the standard care arm will not receive hemoperfusion when lextracorporeal membrane oxygenation (ECMO) is commenced.

Interventions

hemoperfusionDEVICE

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.

hemoperfusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Interventions

Hemoperfusion

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Dannuo Han

    Beijing Anzhen Hospital

    STUDY CHAIR

Central Study Contacts

Xiaotong Hou, PhD., Md.

CONTACT

86 18911662932xt.hou@ccmu.edu.cn

Dannuo Han

CONTACT

13720055429handannuo@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Center for Cardiac Intensive Care

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 5, 2018

Study Start

October 19, 2018

Primary Completion

January 31, 2022

Study Completion

December 31, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

CN(1)