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

Not Applicable

Recruiting

• Conditions: Extracorporeal Membrane Oxygenation; Septic Shock; Septic Cardiomyopathy; Cardiogenic Shock
• Interventions: Procedure: Extracorporeal Membrane Oxygenation (ECMO)

• Registration Number: NCT05184296
• Lead Sponsor: Second Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-07
• Study First Posted: 2022-01-11
• Study Start: 2023-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort 1	Extracorporeal Membrane Oxygenation (ECMO)	Participants taking VA-ECMO during the period of study are referred to as cohort 1

Primary Outcome Measures

Name	Time	Method
30-day survival	From date of enrolled (D0) until date of death from any cause or day-30, whichever came first	survival rate at day-30

Secondary Outcome Measures

Name	Time	Method
ICU survival rate	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
6-month survival	From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first	survival rate at 6-month
quality of life for long-term survival	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.
hospital survival	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
hospital length of stay (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	hospital LOS
successful rate of ECMO weaning	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
the number of days alive without CRRT, mechanical ventilation and vasopressor	between Day 0 and up to Day 30	the numbers of CRRT-free days, mechanical ventilation-free days and vasopressor-free days
ICU length of stay (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	ICU LOS
long-term survivors' cardiac function	at day-30 and 6-month	LVEF evaluated according to Doppler echocardiography

Trial Locations

Locations (1)

Chen Weiyan; 🇨🇳 Guangzhou, Guangdong, China