Metabolic changes after an ICU stay and long-term physical recovery in ICU survivors

Long-Term Outcomes and Post-Intensive Care Syndrome: An Explorative, Prospective, Observational Cohort Study to Investigate the Associations Between Metabolic Signatures and Physical Functioning in Critically Ill Patients

We will test whether metabolic changes during and after an ICU stay help explain long-term physical recovery in adults who needed prolonged ICU care.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Gelderse Vallei Hospital (Academic / other)
• Locations: 1 site (Ede, Gelderland)
• Trial ID: NCT07170527 on ClinicalTrials.gov

What this trial studies

This is an observational cohort enrolling adult ICU patients who required ventilatory support or had an expected prolonged ICU stay to measure metabolic signatures during critical illness and track physical functioning over time. Researchers will combine clinical data (age, sex, illness severity) with biomarkers of catabolism, muscle metabolism, inflammation, nutrition, and gut health to identify patterns linked to recovery. Participants will undergo serial sampling during and after ICU admission and standardized functional assessments during follow-up visits. The goal is to find potentially modifiable metabolic factors that predict or influence post-intensive care syndrome outcomes.

Who should consider this trial

Good fit: Adults (≥18 years) who had ventilatory support within 48 hours of ICU admission with an expected duration ≥48 hours, or who had an expected ICU stay of ≥72 hours, are the ideal candidates.

Not a fit: Patients on palliative care or with life expectancy under three months, those with progressive neurological diseases or major preexisting paralysis, or those enrolled in other interventional trials are unlikely to benefit from this observational project.

Why it matters

Potential benefit: If successful, the results could reveal modifiable metabolic targets that guide personalized nutrition, rehabilitation, or other interventions to improve long-term physical recovery after ICU care.

How similar studies have performed: Prior work has linked inflammation and nutrition to recovery after critical illness, but comprehensive metabolic fingerprinting tied to long-term PICS outcomes is largely novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years at time of ICU admission;
* Received ventilatory support (IMV or NIV) within 48 hours after ICU admission with an expected duration of ≥48 hours during ICU stay (irrespective of ICU length of stay); OR
* An expected ICU length of stay of ≥72 hours (irrespective of ventilatory support).

Exclusion Criteria:

* Concurrent participation in an intervention study with an anticipated therapeutic effect on PICS outcomes (physical functioning, cognitive functioning, or mental health status)
* Pre-admission diagnosis of a progressive neurological disease (e.g., Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, progressive forms of multiple sclerosis)
* Participants with neurological paralysis significantly affecting leg function (e.g., spinal cord injury, multiple sclerosis)
* Patients receiving palliative care, with a life expectancy of \<3 months (e.g., hospice care or equivalent)
* Patients who are moribund (i.e., in the final stages of a terminal illness, with imminent death expected)
* Anticipated logistical limitations during recovery phase (e.g., transfer to another hospital, no fixed abode);
* Deemed not suitable to participate based upon the judgement of the treating intensivist.

Where this trial is running

Ede, Gelderland

• Gelderse Vallei Hospital — Ede, Gelderland, Netherlands (Recruiting)

Study contacts

• Study coordinator: Arthur HR van Zanten, MD, PhD

Conditions Post-Intensive Care Syndrome; Critical illness; Intensive Care Unit; Recovery; Long-Term Outcomes