Clinical trial NCT05184296: ExtraCorporeal Membrane Oxygenation in the Therapy for REfractory Septic Shock With Cardiac Function Under Estimated
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
Overall status: RECRUITING
Phase: NA
Conditions: Extracorporeal Membrane Oxygenation
Septic Shock
Septic Cardiomyopathy
Cardiogenic Shock
Keywords: Extracorporeal Membrane Oxygenation
refractory septic shock
septic cardiomyopathy
cardiogenic shock
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 30-day survival
timeFrame: From date of enrolled (D0) until date of death from any cause or day-30, whichever came first
Secondary outcomes:
measure: ICU survival rate
timeFrame: 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
measure: hospital survival
timeFrame: 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
measure: 6-month survival
timeFrame: From date of enrolled (D0) until the date of death from any cause or 6-month, whichever came first
measure: quality of life for long-term survival
timeFrame: at 6-months
measure: successful rate of ECMO weaning
timeFrame: From date of weaning off ECMO until the date of death or 24 hours after ECMO weaning, whichever came first
measure: long-term survivors' cardiac function
timeFrame: at day-30 and 6-month
measure: the number of days alive without CRRT, mechanical ventilation and vasopressor
timeFrame: between Day 0 and up to Day 30
measure: ICU length of stay (LOS)
timeFrame: 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
measure: hospital length of stay (LOS)
timeFrame: 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 outcomes:
measure: safety assessments
timeFrame: from the date of enrolled (D0) until death or day-30, whichever came first.
Locations:
city: Guangzhou
country: China
facility: Chen Weiyan
state: Guangdong
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Zhen-hui Zhang
role: STUDY_DIRECTOR
References: