Critical Illness PolyneuropathyCRIMINE-3NCT04193943
Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
An observational study of Critical Illness Polyneuropathy and Critical Illness Myopathy, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness Polyneuropathy, Critical Illness Myopathy
- How many people
- 130 participants
- Where
- 1 siteItaly
- Study dates
- 18 Jun 2014to 1 May 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Critically Ill Patients
Who may be able to join
- adult patients admitted to Intensive care unit
Who cannot join
- patients in terminal conditions
- patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.
- Medical subject headings
- Polyneuropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
DTComPair-package in R
Measured: up to the comlpete execution of the two peroneal nerve exams,at most an hour
specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
DTComPair-package in R
Measured: up to the comlpete execution of the two peroneal nerve exams, at most an hour
Secondary outcomes (3)
evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable
It will be performed either using Bland-Altman plot and mix model effect
Measured: up to the comlpete execution of the two peroneal nerve exams, at most an hour
correlation between hospital mortality and abnormal peroneal nerve test
Anova
Measured: up to hospital discharge, an average of 6 months
correlation between hospital discharge destination and abnormal peroneal nerve test
Anova
Measured: up to hospital discharge, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start18 Jun 2014
- Primary completion26 Nov 2014
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Illness PolyneuropathyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Seghelini,MD, Università degli Studi di Brescia
- Investigators
- Elisa Seghelini, Principal investigator, II Servizio di Anestesia e Rianimazone, Spedali Civili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193943
- Sponsor's protocol ID
- PN 1700/2014
- Acronym
- CRIMINE-3
- Status last verified
- Dec 2019
- First submitted
- 25 Nov 2019
- Last updated
- 13 Dec 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 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy
- ClinicalTrials.gov ID
- NCT04193943
- Acronym / sponsor ID
- CRIMINE-3 / PN 1700/2014
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 18 Jun 2014 (actual)
- Primary completion
- 26 Nov 2014 (actual)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 11 Dec 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.
Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Critically Ill Patients
Key inclusion criteria (1 listed)
- adult patients admitted to Intensive care unit
Key exclusion criteria (2 listed)
- patients in terminal conditions
- patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)
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
sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
Time frame: up to the comlpete execution of the two peroneal nerve exams,at most an hour
DTComPair-package in R
specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal
Time frame: up to the comlpete execution of the two peroneal nerve exams, at most an hour
DTComPair-package in R
3 secondary outcomes
evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable
Time frame: up to the comlpete execution of the two peroneal nerve exams, at most an hour
correlation between hospital mortality and abnormal peroneal nerve test
Time frame: up to hospital discharge, an average of 6 months
correlation between hospital discharge destination and abnormal peroneal nerve test
Time frame: up to hospital discharge, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Elisa Seghelini principal investigator
II Servizio di Anestesia e Rianimazone, Spedali Civili
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 Critical Illness Polyneuropathy and Critical Illness Myopathy, run by Università degli Studi di Brescia at 1 site in Italy.
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 2 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 13 Dec 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal (time frame: up to the comlpete execution of the two peroneal nerve exams,at most an hour). The study lists 2 primary outcomes in all. 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 13 Dec 2019.