ICU Acquired WeaknessEDXNCT03802500
Neurophysiological Diagnosis for ICU Septic Shock Patients
An observational study of ICU Acquired Weakness, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU Acquired Weakness
- What is being tested?
- Nerve conduction study
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Jan 2019to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.
Who may be able to join
- Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.
Who cannot join
- Hospitalization for more than 7 days before intubation.
- Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale.
- Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs.
- Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease.
- Burn patients admitted to ICU.
- Patient requesting withdrawal of therapies.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
CHUV
Lausanne, Canton of Vaud, 1000
CAROLINE ATTWELL, 0795567994, caroline.attwell@chuv.ch
About this study
Official title: Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study
Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors.
ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness.
The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.
- Conditions
- ICU Acquired Weakness
- Being tested
- Nerve conduction study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve conduction studyDiagnostic test
Also called Peroneal nerve test (PENT test)
Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.
Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).
The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.
PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.
Medical Research Council strength scale
Measured: 72 hours
Secondary outcomes (6)
ICU length of stay
Measured: Up to 6 months
Hospital length of stay
Measured: Up to 6 months
Discharge destination
Measured: At discharge from hospital, up to 6 months
Length of ventilatory support
Measured: At extubation, up to 6 months
Extubation failure rate
Patients requiring reintubation 72 hours after failed first extubation
Measured: up to 72 hours, after first extubation
Time elapsed between endotracheal intubation and first out-of-bed mobilization
Measured: up to 6 months, at first out-of-bed mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start23 Jan 2019
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (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 Centre Hospitalier Universitaire VaudoisThe 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAROLINE ATTWELL, Centre Hospitalier Universitaire Vaudois
- Investigators
- Karin Diserens, PD-MER, Study director, NRA Unit. CHUV.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802500
- Sponsor's protocol ID
- NRA-01
- Acronym
- EDX
- Status last verified
- Oct 2019
- First submitted
- 12 Dec 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Electromyographic Evaluation of the ICU-acquired Weakness in Septic Shock Patients Ventilated Longer Than 72 Hours: Neurophysiological Study
- ClinicalTrials.gov ID
- NCT03802500
- Acronym / sponsor ID
- EDX / NRA-01
- Conditions
- ICU Acquired Weakness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Jan 2019 (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.
Patients hospitalized in the Intensive Care Unit (ICU) are at risk for developing severe disabilities, physical or cognitive. In particular, ICU-acquired weakness is frequent. The causes of this weakness are multiple and the physiopathology is still not fully understood. Immobilization in bed and sepsis are known risk factors.
ICU-acquired weakness has been associated with prolonged mechanical ventilation duration, and increased in ICU and hospital length of stay. It has also been associated with significant decrease in functional capacity and with higher mortality. An early screening using a specific diagnostic protocol could help improving the management of patients suffering from ICU acquired weakness.
The aim of this study is to early detect ICU acquired weakness in patients suffering from septic shock and ventilated for more than 72 hours.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.
Key inclusion criteria (1 listed)
- Patients admitted to the ICU with a septic shock and ventilated for more than 72 hours.
Key exclusion criteria (6 listed)
- Hospitalization for more than 7 days before intubation.
- Functional disability at admission of ≥4 (Requires constant nursing care and attention, bedridden, incontinent) in the Modified Rankin Scale.
- Lower limb disorders precluding nerve conduction studies (NCV) and electromyography (EMG), such as clinical edema of the lower limbs, or fractures, amputation, and plaster casts of the lower limbs.
- Evidence of altered neuromuscular transmission at repetitive stimulation test either caused by neuromuscular blocking agents or disease.
- Burn patients admitted to ICU.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve conduction studyAlso: Peroneal nerve test (PENT test)Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally. Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM). The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU. PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV. | Diagnostic test | – |
Primary outcome
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours.
Time frame: 72 hours
Medical Research Council strength scale
6 secondary outcomes
ICU length of stay
Time frame: Up to 6 months
Hospital length of stay
Time frame: Up to 6 months
Discharge destination
Time frame: At discharge from hospital, up to 6 months
Length of ventilatory support
Time frame: At extubation, up to 6 months
Extubation failure rate
Time frame: up to 72 hours, after first extubation
Time elapsed between endotracheal intubation and first out-of-bed mobilization
Time frame: up to 6 months, at first out-of-bed mobilization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Karin Diserens, PD-MER study director
NRA Unit. CHUV.
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 Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 6 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 4 Oct 2019. 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 Switzerland. 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 CAROLINE ATTWELL (0789242320, caroline.attwell@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of ICU-acquired weakness in septic shock patients ventilated for more than 72 hours. (time frame: 72 hours). 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 4 Oct 2019.