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

NCT05184296 | Recruiting DMC

• 1 other identifier: ICU-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Extracorporeal Membrane Oxygenation; Septic Shock; Septic Cardiomyopathy; Cardiogenic Shock

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

• 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

• 6-month survival

  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

  at 6-months

• 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

Other Outcomes (1)

• safety assessments

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

Study Arms (2)

cohort 1

EXPERIMENTAL

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

Procedure: Extracorporeal Membrane Oxygenation (ECMO)

cohort 2

NO INTERVENTION

Patients receiving only conventional therapy without ECMO belong to cohort 2

Interventions

Extracorporeal Membrane Oxygenation (ECMO) PROCEDURE

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.

cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Chen Weiyan

Guangzhou, Guangdong, 510260, China

RECRUITING

Related Publications (1)

• Chen WY, Guo ZB, Kong TY, Chen WX, Chen XH, Yang Q, Wen YC, Wen QR, Zhou F, Xiong XM, Wen DL, Zhang ZH. ExtraCorporeal Membrane Oxygenation in the therapy for REfractory Septic shock with Cardiac function Under Estimated (ECMO-RESCUE): study protocol for a prospective, multicentre, non-randomised cohort study. BMJ Open. 2024 Jun 10;14(6):e079212. doi: 10.1136/bmjopen-2023-079212.

  PMID: 38858161 DERIVED

MeSH Terms

Conditions

Shock, Septic; Shock, Cardiogenic

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Zhen-hui Zhang

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Wei-yan Chen

CONTACT

+8613751845652; sam11124@163.com

De-liang Wen

CONTACT

+8618126780249; deliangwen@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 11, 2022
• Study Start: May 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)