Japan Intensive Care Consortium: Nationwide Effort for Extracorporeal Membrane Oxygenation Care Optimization and Excellence Study: Study Protocol

Abstract

Background: Extracorporeal membrane oxygenation (ECMO) is a vital intervention in patients with severe cardiogenic shock or respiratory failure who are unresponsive to conventional therapies. Despite advances in ECMO technology and management, complications such as infections, renal dysfunction, and post-intensive care syndrome remain significant challenges that contribute to high mortality. Existing registries have provided valuable insights but lack detailed data on infection management, rehabilitation practices, and other granular aspects of ECMO care. The Japan Intensive Care ECMO Consortium: Nationwide Effort for ECMO Care Optimization and Excellence (ECMO NEXT) study aims to address these gaps by establishing a comprehensive multicenter study in Japan.

Methods: This is a multicenter, retrospective cohort study conducted at 22 healthcare institutions in Japan, with data collected on ECMO cases between January 2018 and December 2023. Adults aged ≥18 years who underwent ECMO in the intensive care unit (ICU) during this period will be eligible. This study will focus on six predefined themes: post-decannulation fever, infection epidemiology, ventilator settings, ECMO-associated acute kidney injury and electrolyte abnormalities, rehabilitation practices, and venoarterial ECMO in toxicological emergencies and septic shock scenarios. Data-including clinical course, laboratory results, rehabilitation details, and outcomes-will be collected using a standardized electronic case report form on the Research Electronic Data Capture platform. Statistical models, including propensity score-based analyses, will be used to adjust for confounders and assess attributable risks.

Conclusions: The ECMO NEXT study provides high-resolution data to address the gaps in ECMO research, particularly in ICU management and post-ECMO recovery.

Keywords: Acute Kidney Injury; Critical Care; Extracorporeal Membrane Oxygenation; Infection Control; Rehabilitation.

Fig. 1. Location of participating hospitals in the ECMO NEXT study

Geographical distribution of the 22 participating hospitals across Japan contributing to the ECMO NEXT study as of January 2025.

Fig. 2. Representative image of muscle mass quantification using CT imaging

Representative CT images showing quantification of skeletal muscle at the T6 (respiratory muscles) (A) and L3 (skeletal muscles) (B) levels. Regions of interest are highlighted and muscle area and density are calculated using predefined Hounsfield Unit (HU) ranges.