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

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ClinicalTrials.gov Identifier: NCT03345758
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
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.

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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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03345758


Contacts
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Contact: ling liu, MD 13851435472 liulingdoctor@126.com

Locations
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China, Jiangsu
Nanjing Zhong-Da Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Ling Liu, MD.    86-25-83272201    liuling6600@yahoo.com   
Contact: Haibo Qiu, PhD.,MD.    86-25-83272200    haiboq2200@yahoo.com   
Principal Investigator: Ling Liu, MD.         
Sponsors and Collaborators
Southeast University, China
Investigators
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Study Director: Haibo Qiu, MD professor

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Responsible Party: Ling Liu, Director, Southeast University, China
ClinicalTrials.gov 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

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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