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

Primary Purpose

Extracorporeal Membrane Oxygenation, Septic Shock, Septic Cardiomyopathy

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Extracorporeal Membrane Oxygenation (ECMO)

About this trial

This is an interventional treatment trial for Extracorporeal Membrane Oxygenation focused on measuring Extracorporeal Membrane Oxygenation, refractory septic shock, septic cardiomyopathy, cardiogenic shock

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chen WeiyanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cohort 1

cohort 2

Arm Description

Participants taking VA-ECMO during the period of study are referred to as cohort 1

Patients receiving only conventional therapy without ECMO belong to cohort 2

Outcomes

Primary Outcome Measures

30-day survival

survival rate at day-30

Secondary Outcome Measures

ICU survival rate

survival to ICU discharge

hospital survival

survival to hospital discharge

6-month survival

survival rate at 6-month

quality of life for long-term survival

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.

successful rate of ECMO weaning

Successful weaning is defined as maintaining stable condition within 24 hours of ECMO weaning. Analyzed the frequency of patients who weaning ECMO successfully

the rate of complications potentially related to ECMO treatment

including major bleeding associated with anticoagulants, thrombosis, leg ischemia, cannulation-related injuries and cannula insertion site infection

long-term survivors' cardiac function

LVEF evaluated according to Doppler echocardiography

long-term survivors' cardiac function

LVEF evaluated according to Doppler echocardiography

the number of days alive without CRRT, mechanical ventilation and vasopressor

the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days

ICU length of stay (LOS)

ICU LOS

hospital length of stay (LOS)

hospital LOS

Full Information

NCT ID

NCT05184296

First Posted

December 20, 2021

Last Updated

November 21, 2022

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05184296

Brief Title

ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated

Acronym

ECMO-RESCUE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extracorporeal Membrane Oxygenation, Septic Shock, Septic Cardiomyopathy, Cardiogenic Shock

Keywords

Extracorporeal Membrane Oxygenation, refractory septic shock, septic cardiomyopathy, cardiogenic shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cohort 1

Arm Type

Experimental

Arm Description

Participants taking VA-ECMO during the period of study are referred to as cohort 1

Arm Title

cohort 2

Arm Type

No Intervention

Arm Description

Patients receiving only conventional therapy without ECMO belong to cohort 2

Intervention Type

Procedure

Intervention Name(s)

Extracorporeal Membrane Oxygenation (ECMO)

Intervention Description

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.

Primary Outcome Measure Information:

Title

30-day survival

Description

survival rate at day-30

Time Frame

From date of enrolled (D0) until date of death from any cause or day-30, whichever came first

Secondary Outcome Measure Information:

Title

ICU survival rate

Description

survival to ICU discharge

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

Title

hospital survival

Description

survival to hospital discharge

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

Title

6-month survival

Description

survival rate at 6-month

Time Frame

From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first

Title

quality of life for long-term survival

Description

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.

Time Frame

at 6-months

Title

successful rate of ECMO weaning

Description

Successful weaning is defined as maintaining stable condition within 24 hours of ECMO weaning. Analyzed the frequency of patients who weaning ECMO successfully

Time Frame

From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first

Title

the rate of complications potentially related to ECMO treatment

Description

including major bleeding associated with anticoagulants, thrombosis, leg ischemia, cannulation-related injuries and cannula insertion site infection

Time Frame

from the date of enrolled (D0) until death or day-30, whichever came first

Title

long-term survivors' cardiac function

Description

LVEF evaluated according to Doppler echocardiography

Time Frame

at day-30 and 6-month

Title

long-term survivors' cardiac function

Description

LVEF evaluated according to Doppler echocardiography

Time Frame

at day-30 and 6-months

Title

the number of days alive without CRRT, mechanical ventilation and vasopressor

Description

the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days

Time Frame

between Day 0 and up to Day 30

Title

ICU length of stay (LOS)

Description

ICU 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

Title

hospital length of stay (LOS)

Description

hospital 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei-yan Chen

Phone

+8613751845652

sam11124@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

De-liang Wen

Phone

+8618126780249

deliangwen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhen-hui Zhang

Organizational Affiliation

Second Affiliated Hospital of Guangzhou Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Chen Weiyan

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chen Weiyan

Phone

+8613751845652

sam11124@126.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated

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