Working... Menu

Long Term Outcome of Extracorporeal Membrane Oxygenation Patients in China (ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03345758
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Ling Liu, Southeast University, China

Brief 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.

Condition or disease Intervention/treatment
Long-term Outcome Extracorporeal Membrane Oxygenation Other: outcome

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Department of Critical Care Medicine, Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China;
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Group/Cohort Intervention/treatment
ECMO mode,outcome
ECMO mode includes VV-ECMO and VA-ECMO, outcome includes survive condition , physical and mental health, cognitive function and social adaptation
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

Primary Outcome Measures :
  1. survival rate [ Time Frame: August,1,2017-March,1,2020 ]
    survival rate at discharge

Secondary Outcome Measures :
  1. Quality of live [ Time Frame: August,1,2017-March,1,2020 ]
    Questionnaire:mobility,personal care (washing/dressing),usual activities,Pain/discomfort,Anxiety/depression

  2. Cognitive function [ Time Frame: August,1,2017-March,1,2020 ]
    MMSE Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019

Inclusion Criteria:

  • require extracorporeal membrane oxygenation

Exclusion Criteria:

  • irreversible disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03345758

Layout table for location contacts
Contact: ling liu, MD 13851435472

Layout table for location information
China, Jiangsu
Nanjing Zhong-Da Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Ling Liu, MD.    86-25-83272201   
Contact: Haibo Qiu, PhD.,MD.    86-25-83272200   
Principal Investigator: Ling Liu, MD.         
Sponsors and Collaborators
Southeast University, China
Layout table for investigator information
Study Director: Haibo Qiu, MD professor

Layout table for additonal information
Responsible Party: Ling Liu, Director, Southeast University, China Identifier: NCT03345758     History of Changes
Other Study ID Numbers: 20170717
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ling Liu, Southeast University, China:
respiratory failure, circulatory failure