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TOPICS-study

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 - TOPICS study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57551
Enrollment
200
Registered
2024-08-01
Start date
2025-10-13
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-lntensive Care Syndrome, Recovery after critical illness PICS, recovery after critical illness

Interventions

None listed

Sponsors

Ziekenhuis Gelderse Vallei
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 ventilatory support (IMV or NIV) of =48 hours during ICU stay (irrespective of ICU length of stay);ORAn expected ICU length of stay of =72 hours (irrespective of ventilatory support).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The main study endpoint is physical functioning at 3-months post-ICU admission, assessed by multiple outcomes including the physical component score of the Short Form-36 questionnaire, handgrip strength, 30-second chair stand test, m. rectus femoris cross-sectional area, quadriceps muscle layer thickness, rectus femoris muscle layer thickness, rectus femoris echo-intensity, rectus femoris fascial echo-intensity, rectus femoris pinnation angle, subcutaneous tissue layer, calf circumference, and body composition. 

Secondary

MeasureTime frame
Secondary study parameters entail hypercatabolism, muscle metabolism, nutritional status, inflammation, gut health, cognitive function, mental health status, sleep quality, health-related quality of life, and dietary intake. These parameters will be assessed by the means of questionnaires, blood analyses and/or fecal analyses. Besides, ICU admission characteristics and clinical parameters throughout ICU stay will be recorded.

Countries

Netherlands

Contacts

Public ContactNMP Overwater-van den Meijdenberg

Ziekenhuis Gelderse Vallei

noverwater@zgv.nl+31318434119

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)