ICU Acquired WeaknessICU-AWNCT04932330
Risk Factors of ICU-acquired Weakness
An observational study of ICU Acquired Weakness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICU Acquired Weakness
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
man huang, phD contact
China1 site, 1 recruiting
- Recruiting
Xinyi Chen
Hangzhou, Please Select, 310000
xinyi chen, 19858875700, chenxinyi0323@zju.edu.cn
man huang
About this study
Official title: 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.
- Conditions
- ICU Acquired Weakness
- Keywords
- ICU Acquired Weakness, Extracorporeal Membrane Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Mar 2017
- Primary completion1 Mar 2020
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Acquired WeaknessStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932330
- Sponsor's protocol ID
- 2021-0041
- Acronym
- ICU-AW
- Status last verified
- Jun 2021
- First submitted
- 1 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: One year after the article was published, and the opening lasted for one year
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU-acquired Weakness in Extracorporeal Membrane Oxygenation Support: Frequency and Risk Factors
- ClinicalTrials.gov ID
- NCT04932330
- Acronym / sponsor ID
- ICU-AW / 2021-0041
- Conditions
- ICU Acquired Weakness
- Keywords
- ICU Acquired Weakness, Extracorporeal Membrane Oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences between ICU-acquired weakness in patients receiving extracorporeal membrane oxygenation support
Time frame: 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.
1 secondary outcome
Frequency of ICU-acquired weakness in in patients receiving extracorporeal membrane oxygenation support
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: Yes. One year after the article was published, and the opening lasted for one year
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
man huang, phD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Acquired Weakness, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xinyi chen, master (19858875700, chenxinyi0323@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between ICU-acquired weakness in patients receiving extracorporeal membrane oxygenation support (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.