NCT03345758

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

6.4 years

First QC Date

October 15, 2017

Last Update Submit

July 17, 2022

Conditions

Long-term OutcomeExtracorporeal Membrane Oxygenation

Keywords

respiratory failure, circulatory failure

Outcome Measures

Primary Outcomes (1)

  • survival rate

    survival rate at discharge

    August,1,2017-March,1,2020

Secondary Outcomes (2)

  • Quality of live

    August,1,2017-March,1,2020

  • Cognitive function

    August,1,2017-March,1,2020

Study Arms (1)

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

Interventions

outcomeOTHER

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

ECMO mode,outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients treated with extracorporeal membrane oxygenation during March,1,2017 to March,1,2019

You may qualify if:

  • require extracorporeal membrane oxygenation

You may not qualify if:

  • irreversible disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Zhong-Da Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyShock

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Haibo Qiu, MD

    professor

    STUDY DIRECTOR

Central Study Contacts

ling liu, MD

CONTACT

13851435472liulingdoctor@126.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 15, 2017

First Posted

November 17, 2017

Study Start

August 1, 2017

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)