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

Septic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05184296
• Other study ID #: ICU-02
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: November 2023
• Source: Second Affiliated Hospital of Guangzhou Medical University
• Contact: Wei-yan Chen
• Phone: +8613751845652
• Email: sam11124[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
China	Chen Weiyan	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	safety assessments	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.
Primary	30-day survival	survival rate at day-30	From date of enrolled (D0) until date of death from any cause or day-30, whichever came first
Secondary	ICU survival rate	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
Secondary	hospital survival	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
Secondary	6-month survival	survival rate at 6-month	From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first
Secondary	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.	at 6-months
Secondary	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	From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first
Secondary	long-term survivors' cardiac function	LVEF evaluated according to Doppler echocardiography	at day-30 and 6-month
Secondary	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	between Day 0 and up to Day 30
Secondary	ICU length of stay (LOS)	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
Secondary	hospital length of stay (LOS)	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