Risk Factors of ICU-acquired Weakness (ICU-AW)

ICU-acquired Weakness in Extracorporeal Membrane Oxygenation Support: Frequency and Risk Factors

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.

Study Overview

• Status: Recruiting
• Conditions: ICU Acquired Weakness

• Study Type: Observational
• Enrollment (Anticipated): 85

Contacts and Locations

• Study Contact: Name: xinyi chen, master; Phone Number: 19858875700; Email: chenxinyi0323@zju.edu.cn

Study Locations

• China
  • Please Select
    • Hangzhou, Please Select, China, 310000
      • Recruiting
      • Xinyi Chen
      • Contact: xinyi chen; Phone Number: 19858875700; Email: chenxinyi0323@zju.edu.cn
      • Contact: man huang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of ICU-acquired weakness in in patients receiving extracorporeal membrane oxygenation support	We calculated the prevalence of ICU-acquired weakness on the patients included in our research.	1 day

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2017
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (ACTUAL): June 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Extracorporeal Membrane Oxygenation; ICU Acquired Weakness
• Additional Relevant MeSH Terms: Asthenia
• Other Study ID Numbers: 2021-0041 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: One year after the article was published, and the opening lasted for one year

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No