臨床研究等提出・公開システム

Date of registration	Jan. 17, 2025
Last modified on	Jan. 17, 2025
Trial ID	jRCT1040240168

Scientific Title	Japan Intensive Care ECMO Consortium: Nationwide Effort for ECMO Care Optimization and eXcellence sTudy (ECMO NEXT study)
Public Title	Japan Intensive Care ECMO Consortium: Nationwide Effort for ECMO Care Optimization and eXcellence sTudy (ECMO NEXT study)

Contact for Scientific Queries	Name	Kasugai Daisuke
	Affiliation	Department of Emergency and Clinical Care Medicine
	Address	Nagoya University Graduate School of Medicine,65 tsurumai-cho,sho-wa,Nagoya,464-8550,Japan
	Telephone	+81-52-741-2111
	E-mail	dkasugai@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Kasugai Daisuke
	Affiliation	Department of Emergency and Clinical Care Medicine
	Address	Nagoya University Graduate School of Medicine,65 tsurumai-cho,sho-wa,Nagoya,466-8550,Japan
	Telephone	+81-52-741-2111
	E-mail	dkasugai@med.nagoya-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 01, 2018
Target sample size		2500
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Between January 1, 2018, and December 31, 2023, individuals meeting the following criteria: Aged 18 years or older Required ECMO management in the intensive care unit of Nagoya University Hospital or Participating sites
	Exclusion Criteria	None (Appropriate exclusion criteria will be defined for each specific clinical question.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Extracorporeal Membrane Oxygenation
Intervention(s)		none
Health Condition(s) Keyword		Extracorporeal Membrane Oxygenation
Health Condition(s) Code		Extracorporeal Membrane Oxygenation
Primary Outcome(s)		Weaning failure within 30 days of ECMO decannulation, which is a composite of death, ECMO reinitiation, or bridging to transplantation (left ventricular assist device or heart/lung transplantation) Inhospital moratality
Secondary Outcome(s)		Laboratory data. CT Imaging. Functional outcomes were assessed using standardized scales, including the Johns Hopkins Safe Patient Handling Mobility, Barthel Index, ICU Mobility Scale, Medical Research Council Score, and Clinical Frailty Scale. These assessments were performed at three specific time points: ICU discharge, seven days after ICU discharge, and hospital discharge.

Primary Sponsor	None

Source of Monetary Support	Nagoya University
Secondary Sponsor	Not applicable

Source of Monetary Support	Japan Society for the Promotion of Science

Name of Certified Review Board	Ethical Review Committee for Observational Studies of Nagoya University Hospital
Address	65 tsurumai-cho, showa-ku, nagoya, Aichi
Telephone	+81-52-744-2423
E-Mail	iga-shinsa@t.mail.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 25, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none