Critical-illness–related muscle and nerve weakness in adults hospitalized outside the ICU

Critical Illness Weakness Outside the Intensive Care Unit. A Prospective Cohort Study.

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
• Enrollment: 300 (estimated)
• Sex: All
• Sponsor: Istituto Clinico Humanitas (Academic / other)
• Locations: 1 site (Rozzano)
• Trial ID: NCT07478367 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rozzano

• Humanitas Research Institute — Rozzano, Italy (Recruiting)

Study contacts

• Principal investigator: Pietro E Doneddu — Humanitas Research Institute
• Study coordinator: Pietro E Doneddu, MD

Conditions Critical Illness Polyneuromyopathy; Critical Illness Polyneuropathy; Critical Illness Myopathy; critical illness neuropathy; critical illness myopathy; critical illness weakness; Non-ICU hospitalized patients; polyneuropathy