Actively Recruiting

Age: 18Years +
All Genders
NCT07170527

Long-Term Outcomes and Post-Intensive Care Syndrome: Investigating the Associations Between Metabolic Signatures and Physical Functioning in Critically Ill Patients

Led by ARH van Zanten, MD PhD · Updated on 2026-02-12

200

Participants Needed

1

Research Sites

150 weeks

Total Duration

On this page

Sponsors

A

ARH van Zanten, MD PhD

Lead Sponsor

D

Danone Global Research & Innovation Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Despite being young, healthy, and physically fit, some intensive care unit (ICU) patients experience significantly worse functional recovery after critical illness than older patients with multiple comorbidities although a poor precondition seems to be associated with worse ICU outcomes. This paradox highlights a fundamental gap in our understanding of the determinants of long-term recovery. While nonmodifiable factors such as age and pre-existing disease explain part of the variation, they cannot fully account for the wide heterogeneity in outcomes. Metabolic disturbances during critical illness, such as hypercatabolism, impaired muscle metabolism, nutritional deficits, systemic inflammation, and disruption of gut health, are likely to influence recovery trajectories, yet remain poorly characterized. Because these processes represent potentially modifiable targets, combining their evaluation with nonmodifiable patient characteristics is essential for unraveling the complex, multifactorial mechanisms underlying post-intensive care syndrome (PICS). This explorative, prospective, observational study aims to investigate the associations between metabolic signatures during the acute phase of critical illness and PICS outcomes throughout the recovery trajectory of ICU survivors, with a primary focus on physical functioning. In addition, the study explores the longitudinal course of metabolic parameters from ICU admission up to 12 months post-discharge, and whether these signatures can help identify distinct recovery phenotypes. Participants will be followed for 12 months, with study assessments at ICU admission, ICU discharge, and at 3-, 6-, and 12-months post-ICU admission.

CONDITIONS

Official Title

Long-Term Outcomes and Post-Intensive Care Syndrome: Investigating the Associations Between Metabolic Signatures and Physical Functioning in Critically Ill Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �318 years at ICU admission
  • Received mechanical ventilation (invasive or non-invasive) within 48 hours after ICU admission and expected to receive ventilatory support for at least 48 hours during ICU stay
  • Expected ICU length of stay of at least 72 hours regardless of ventilatory support
Not Eligible

You will not qualify if you...

  • Participation in another intervention study affecting physical, cognitive, or mental health outcomes
  • Pre-existing progressive neurological disease (e.g., Alzheimer's, Parkinson's, ALS, progressive multiple sclerosis)
  • Neurological paralysis significantly affecting leg function (e.g., spinal cord injury, multiple sclerosis)
  • Receiving palliative care with life expectancy less than 3 months
  • Being in final stages of terminal illness with imminent death expected
  • Expected logistical difficulties during recovery phase (e.g., transfer, no fixed address)
  • Considered unsuitable for participation by the treating intensivist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Gelderse Vallei Hospital

Ede, Gelderland, Netherlands, 6716 RP

Actively Recruiting

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Research Team

A

Arthur HR van Zanten, MD, PhD

CONTACT

N

Noortje MP Overwater, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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