Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China

Extracorporeal Membrane Oxygenation Clinical Trial

— ECMO  

Official title:

Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03345758
• Other study ID #: 20170717
• Status: Recruiting
• Start date: August 1, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Southeast University, China
• Contact: ling liu, MD
• Phone: 13851435472
• Email: liulingdoctor[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Outcomes and Long-term Quality-of-life of Patients requiring Extracorporeal Membrane Oxygenation are not known in china. A prospective study survey will be performed to assess the long-term outcome of these patients.

Description:

Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2015 to March 1,2019 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• require extracorporeal membrane oxygenation

Exclusion Criteria:

• irreversible disease

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation
• Long-term Outcome

Intervention

Other:
• outcome
telephone to patients to finish SF-36 (the MOS item short from health survey,SF-36),EQ-5D(EuroQol-5 Dimensions,EQ-5D), AMT-4(Abbreviated Mental Test-4,AMT-4)and MMSE(Mini-mental State Examination,MMSE) to make assessments of their physical and mental health, cognitive function and social adaptation after discharge

Locations

Country	Name	City	State
China	Nanjing Zhong-Da Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Southeast University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	survival rate at discharge	August,1,2017-March,1,2020
Secondary	Quality of live	Questionnaire:mobility,personal care (washing/dressing),usual activities,Pain/discomfort,Anxiety/depression	August,1,2017-March,1,2020
Secondary	Cognitive function	MMSE Questionnaire	August,1,2017-March,1,2020