Critical-illness–related muscle and nerve weakness in adults hospitalized outside the ICU
Official title: Critical Illness Weakness Outside the Intensive Care Unit. A Prospective Cohort Study.
Run by Istituto Clinico Humanitas · NCT07478367 · Data updated 2026-11-12
This project will test how often adults hospitalized with acute illness outside the ICU develop severe muscle and nerve weakness by comparing patients with organ failure to those without.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano) |
| Status | Recruiting |
| Started | November 18, 2025 |
| Main results expected | October 30, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07478367 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18 years) hospitalized for acute illness on non-ICU wards who can provide informed consent and meet either the organ-failure (SOFA-based) or control cohort criteria.
✕Probably not a fit
Patients with preexisting peripheral neuropathy or myopathy, those with conditions preventing electrophysiological testing, or those unable to participate in clinical evaluation (e.g., coma or severe agitated delirium) are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort enrolling adults admitted to non-ICU medical or semi-intensive wards. Patients are grouped by organ dysfunction using SOFA criteria (SOFA ≥ 2 or ΔSOFA ≥ 2 for the critical illness cohort, SOFA < 2 throughout hospitalization for controls). Clinical neurological exams and electrophysiological testing are used to identify critical illness polyneuropathy and myopathy and to describe their clinical features. The study compares prevalence, severity, and short-term functional outcomes of neuromuscular involvement between the two cohorts.
Why it matters
Potential benefit: If successful, this work could improve recognition of neuromuscular weakness outside the ICU and support earlier diagnosis and targeted rehabilitation to reduce long-term disability.
How similar studies have gone: Prior research has documented critical illness polyneuropathy and myopathy in ICU patients, but studies focused on non-ICU hospitalized patients are limited and this application of ICU findings to ward patients is relatively underexplored.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Hospitalization for acute illness in a non-ICU unit * For the critical illness cohort: presence of organ failure defined as a SOFA score ≥ 2 at admission or an increase (ΔSOFA) ≥ 2 during hospitalization * For the control cohort: SOFA score \< 2 throughout hospitalization * Ability to provide written informed consent Exclusion Criteria: * History of peripheral neuropathy, myopathy, or other neuromuscular disorders (e.g., myasthenia gravis) * Conditions affecting the lower limbs that prevent electrophysiological testing * Delirium with agitation preventing clinical evaluation * Coma or inability to assess muscle strength
Where it's running
-
Humanitas Research Institute
Rozzano, Italy Recruiting
Study contacts
- Principal investigator: Pietro E Doneddu — Humanitas Research Institute
- Study coordinator: Pietro E Doneddu, MD
- Email: pietro.doneddu@hunimed.eu
- Phone: +39 0282247761
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.