ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE)

February 19, 2024 updated by: Second Affiliated Hospital of Guangzhou Medical University

ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated (ECMO-RESCUE): a Prospective, Multicenter, Non-randomized Cohort Study

The ECMO-RESCUE study is a prospective, multicenter, non-randomized, cohort study. In this study, we aimed to assessed whether VA-ECMO treatment can improve the 30-day survival rate of patients with sepsis-induced refractory cardiogenic shock.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients who meet inclusion criteria and have no exclusion criteria are considered to be enrolled. During the period of study, the participants can decide whether to accept ECMO based on their personal conditions. If a patient is willing to accept ECMO treatment, we initiate VA-ECMO within 6 hours. Participants taking VA-ECMO during the period of study are referred to as cohort 1, and patients receiving only conventional therapy without ECMO belong to cohort 2. 30-day survival will be accessed to evaluate the survival benefit from ECMO therapy for sepsis-induced refractory cardiogenic shock.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • Recruiting
        • Chen Weiyan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 75 years.
  • Patients admitted into ICU and diagnosed as septic shock (sepsis-3.0)13, after adequate fluid resuscitation, high-dose vasoactive drug application [vasoactive inotropic score (VIS) > 120] and conventional therapy together with at least one of the following criteria: (1) sustained hypotension [mean arterial pressure (MAP) < 65 mmHg]; (2) persistent lactacemia (two consecutive values > 5 mmol/L with at least 30 min interval between samples), with non-decreasing trend on steady doses of inotropes and/or vasopressors; (3) persistent low mixed venous blood oxygen saturation (SvO2) (two consecutive values < 55% with at least 30 min interval between samples), with non-increasing trend on steady doses of inotropes and/or vasopressors. The above condition lasts more than 5 hours.
  • Rapidly deteriorating sepsis-induced myocardial impairment is defined by at least one of the following criteria: (1) rapidly deteriorating ventricular function (LVEF < 35%); (2) cardiac index (CI) < 2L/min/m2 (> 3 hr); (3) emerging refractory arrhythmia.
  • Informed consent provided by the patient or person with decisional responsibility.

Exclusion Criteria:

  • Cardiac dysfunction caused by other causes is excluded, such as acute myocardial infarction, chronic heart failure, congenital cardiac disease, myocardial effusion, moderate to severe aortic regurgitation, severe aortic coarctation and so on.
  • High suspicion of pulmonary embolism, tension pneumothorax or cardiac tamponade as a cause of shock.
  • Prolonged cardiac arrest (> 30 min) before ECMO, or CPR survivors remaining comatose.
  • Irreversible condition or meet the inclusion criteria for more than 12 hr.
  • Presence of active bleeding or anticoagulant contraindications.
  • Peripheral artery disease disabling insertion of outflow cannula to femoral artery.
  • Irreversible neurological pathology
  • Severe underlying condition with lift expectancy less than 1 year.
  • Special population, such as pregnancy, acquired immune deficiency syndrome (AIDS).
  • Patient included in another interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort 1
Participants taking VA-ECMO during the period of study are referred to as cohort 1
Procedure: Extracorporeal Membrane Oxygenation (ECMO)
All patients in cohort 1 will initiate ECMO as fast as possible. A maximum of 6 hours is allowed between enrollment and the actual initiation of ECMO. ECMO catheterization and management will be operated by an experienced ECMO team and carried out at the bedside. VA or VAV mode will be chosen according to the patient's condition.
No Intervention: cohort 2
Patients receiving only conventional therapy without ECMO belong to cohort 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day survival
Time Frame: From date of enrolled (D0) until date of death from any cause or day-30, whichever came first
survival rate at day-30
From date of enrolled (D0) until date of death from any cause or day-30, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU survival rate
Time Frame: From date of enrolled (D0) until date of death from any cause or date of discharge from ICU, whichever came first, assessed up to 6 months
survival to ICU discharge
From date of enrolled (D0) until date of death from any cause or date of discharge from ICU, whichever came first, assessed up to 6 months
hospital survival
Time Frame: From date of enrolled (D0) until date of death from any cause or date of discharge from hospital, whichever came first, assessed up to 6 months
survival to hospital discharge
From date of enrolled (D0) until date of death from any cause or date of discharge from hospital, whichever came first, assessed up to 6 months
6-month survival
Time Frame: From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first
survival rate at 6-month
From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first
quality of life for long-term survival
Time Frame: at 6-months
evaluate through EuroQol Five Dimensions Questionnaire Descriptive System at 6-month within survivors, the minimum value is 3, the maximum value is 15, higher scores mean a worse state.
at 6-months
successful rate of ECMO weaning
Time Frame: From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first
Successful weaning is defined as maintaining stable condition within 24 hours of ECMO weaning. Analyzed the frequency of patients who weaning ECMO successfully
From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first
long-term survivors' cardiac function
Time Frame: at day-30 and 6-month
LVEF evaluated according to Doppler echocardiography
at day-30 and 6-month
the number of days alive without CRRT, mechanical ventilation and vasopressor
Time Frame: between Day 0 and up to Day 30
the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days
between Day 0 and up to Day 30
ICU length of stay (LOS)
Time Frame: From date of enrolled (D0) until the date of death from any cause or discharge from ICU, whichever came first, assessed up to 6 month
ICU LOS
From date of enrolled (D0) until the date of death from any cause or discharge from ICU, whichever came first, assessed up to 6 month
hospital length of stay (LOS)
Time Frame: From date of enrolled (D0) until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 6 month
hospital LOS
From date of enrolled (D0) until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety assessments
Time Frame: from the date of enrolled (D0) until death or day-30, whichever came first.
the rate of complications potentially related to ECMO treatment, including major bleeding associated with anticoagulants, thrombosis, leg ischemia and cannulation-related injuries.
from the date of enrolled (D0) until death or day-30, whichever came first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Investigators

  • Study Director: Zhen-hui Zhang, Second Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 7, 2022

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICU-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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