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ICU-AW: Risk Factors of ICU-acquired Weakness

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04932330
Collaborator
(none)
85
Enrollment
1
Location
63
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    85 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    ICU-acquired Weakness in Extracorporeal Membrane Oxygenation Support: Frequency and Risk Factors
    Actual Study Start Date :
    Mar 1, 2017
    Actual Primary Completion Date :
    Mar 1, 2020
    Anticipated Study Completion Date :
    Jun 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Differences between ICU-acquired weakness in patients receiving extracorporeal membrane oxygenation support [1 day]

      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.

    Secondary Outcome Measures

    1. Frequency of ICU-acquired weakness in in patients receiving extracorporeal membrane oxygenation support [1 day]

      We calculated the prevalence of ICU-acquired weakness on the patients included in our research.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Xinyi Chen Hangzhou Please Select China 310000

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04932330
    Other Study ID Numbers:
    • 2021-0041
    First Posted:
    Jun 21, 2021
    Last Update Posted:
    Jun 21, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    ICU Acquired Weakness
    Extracorporeal Membrane Oxygenation
    Additional relevant MeSH terms:
    Asthenia

    Study Results

    No Results Posted as of Jun 21, 2021