NCT04932330

Brief Summary

We conducted a retrospective study of critical ill patients who used ECMO during their ICU stay. ICU-AW was diagnosed at the time when patients discharged and had a Medical Research Council (MRC) sum score \< 48 out of a maximal score of 60. We divided patients to ICU-acquired weakness group and no ICU-acquired weakness group and compared their clinical characteristics. Baseline characteristics and therapy details were collected from the case report forms and inspection reports. Univariable analysis and logistic regression analysis were used to analyze clinical characteristics of individuals and to find risk factors of ICU-AW.

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
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

June 1, 2021

Last Update Submit

June 11, 2021

Conditions

Keywords

ICU Acquired WeaknessExtracorporeal Membrane Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Differences between ICU-acquired weakness in patients receiving extracorporeal membrane oxygenation support

    We compared the clinical characteristics between ICU-acquired weakness group and no ICU-acquired weakness group by univariate analysis . Then we used logistic regression analysis and found out differences of ICU-acquired weakness.

    1 day

Secondary Outcomes (1)

  • Frequency of ICU-acquired weakness in in patients receiving extracorporeal membrane oxygenation support

    1 day

Study Arms (2)

ICU-acquired weakness group

Patients receiving extracorporeal membrane oxygenation support who had a Medical Research Council (MRC) sum score \< 48 out of a maximal score of 60 when discharged.

no ICU-acquired weakness group

Patients receiving extracorporeal membrane oxygenation support who had a Medical Research Council (MRC) sum score ≥ 48 out of a maximal score of 60 when discharged.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

There were 85 patients used extracorporeal membrane oxygenationbetween March 2017 to March 2020. Among the 85 patients, 22 patients presented exclusion criteria and 63 patients were included in the final analysis.

You may qualify if:

  • Critical ill patients who used extracorporeal membrane oxygenation during their ICU stay. Patients were recruited from the general ICU of the second affiliated hospital of Zhejiang University, between March 2017 to March 2020.

You may not qualify if:

  • Patients who was less than 18 years old, had been proven or suspected neurological impairment, using extracorporeal membrane oxygenation less than 24 hours, severe head or spinal cord injury and pregnant woman.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinyi Chen

Hangzhou, Please Select, 310000, China

RECRUITING

Central Study Contacts

xinyi chen, master

CONTACT

man huang, phD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 21, 2021

Study Start

March 1, 2017

Primary Completion

March 1, 2020

Study Completion

June 1, 2022

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

One year after the article was published, and the opening lasted for one year

Locations