Post-Intensive Care Syndrome (PICS)TOPICSNCT07170527
Long-Term Outcomes and Post-Intensive Care Syndrome: Investigating the Associations Between Metabolic Signatures and Physical Functioning in Critically Ill Patients
An observational study of Post-Intensive Care Syndrome (PICS), run by ARH van Zanten, MD PhD at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Intensive Care Syndrome (PICS)
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Oct 2025to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of 200 adult patients admitted to the ICU of Gelderse Vallei Hospital, Ede, with an expected ICU length of stay of ≥72 hours, or who receive invasive mechanical ventilation (IMV) or non-invasive ventilation (NIV) within 48 hours after ICU admission and are expected to receive this ventilatory support (IMV or NIV) for ≥48 hours.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Gelderse Vallei Hospital
Ede, Gelderland, 6716 RP
Arthur HR van Zanten, MD, PhD, +31318435964, zantena@zgv.nl
Arthur HR van Zanten, MD, PhD
About this study
Official title: 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
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.
Read the detailed description
Yearly, more than 70.000 patients are admitted to the intensive care unit (ICU) in the Netherlands. Although survival rates from critical illness have improved over the last decades, still patients suffer from profound weakness and functional impairments, collectively referred to as post-intensive care syndrome (PICS). PICS encompasses a cluster of long-lasting physical, cognitive, and mental health problems that have a severe impact on patients' quality of life. Studies investigating strategies to improve recovery after critical illness have shown limited effectiveness. This might be due to heterogeneous recovery trajectories observed among ICU survivors. Research has focussed on the associations between non-modifiable factors (e.g., age, sex and disease severity) and PICS outcomes. However, comprehensive assessment of potentially modifiable metabolic signatures (such as hypercatabolism, muscle metabolism, nutritional status, inflammatory response, and gut health) is lacking. These modifiable factors might be of interest as these likely shape the recovery trajectory of critical illness survivors. This approach, by combining the assessment of nonmodifiable factors together with potentially modifiable factors, is essential for understandiing the complex, multifactorial, pathophysiological mechanisms underlying PICS.
The TOPICS study aims to explore the associations between modifiable factors during critical illness (such as hypercatabolism, muscle metabolism, nutritional status, inflammatory response, and gut health), and physical and psychological functioning in ICU survivors. The main questions it aims to answer are:
- What are the associations between metabolic signatures during the acute phase of critical illness and physical functioning 3-months post-ICU admission?
- What are the associations between metabolic signatures during the acute phase of critical illness and physical functioning across different time points in the recovery phase?
- What are the associations between metabolic signatures during the acute phase of critical illness and psychological functioning (cognitive functioning and mental health status) across different time points during the recovery phase?
- What is the trajectory of PICS outcomes, quality of life and metabolic parameters during one year following ICU admission?
- Can distinct patient phenotypes with different recovery trajectories be identified based on metabolic and physical functioning outcomes?
The study is a monocentre, longitudinal, explorative, prospective, observational study. Study measurements will be performed upon ICU admission, and in the recovery period (ICU discharge, 3-, 6-, and 12-months post-ICU admission). Study procedures include:
- Completion of questionnaires on health-related quality of life, cognitive functioning, mental health status, and sleep quality.
- Assessment of physical functioning.
- Collection of blood samples.
- Collection of fecal samples.
- Assessment of dietary intake.
The study population will consist of 200 adult patients admitted to the ICU of Gelderse Vallei Hospital, Ede, with an expected ICU length of stay of ≥72 hours, or who receive invasive mechanical ventila-tion (IMV) or non-invasive ventilation (NIV) within 48 hours after ICU admission and are ex-pected to receive this ventilatory support (IMV or NIV) for ≥48 hours.
- Conditions
- Post-Intensive Care Syndrome (PICS)
- Keywords
- Post-Intensive Care Syndrome (PICS), Critical illness, Intensive Care Unit (ICU), Recovery, Long-Term Outcomes
- Medical subject headings
- postintensive care syndrome, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Adult patients with an expected ICU length of stay of ≥72 hours, or who receive (non-) invasive mechanical ventilation (IMV or NIV) within 48 hours after ICU admission with an expected ventilatory support duration of at least 48 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective physical functioning
Assessed by the Physical Component Score (PCS) of the Short Form-36 (SF-36) questionnaire, ranging from 0 to 100. Scores above or below the average of 50 indicate better or worse physical health compared to the general population, respectively.
Measured: 3-months post-ICU admission
Handgrip strength
Assessed with Jamar dynamometer, measured in kilograms (kg).
Measured: 3-months post-ICU admission
Leg strength and endurance
Assessed by the 30-second chair stand test (30sCST)
Measured: 3-months post-ICU admission
Muscle size
Assessed by muscle ultrasound of the quadriceps muscles
Measured: 3-months post-ICU admission
Muscle size
Assessed by calf circumference, measured in cm
Measured: 3-months post-ICU admission
Body composition
Assessed by bio-electrical impedance analysis (BIA)
Measured: 3-months post-ICU admission
Secondary outcomes (39)
Subjective physical functioning
Assessed by the Physical Component Score (PCS) of the Short Form-36 (SF-36) questionnaire, ranging from 0 to 100. Scores above or below the average of 50 indicate better or worse physical health compared to the general population, respectively.
Measured: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Handgrip strength
Assessed with Jamar dynamometer, measured in kilograms (kg)
Measured: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Leg strength and endurance
Assessed by the 30sCST
Measured: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Muscle size
Assessed by muscle ultrasound of the quadriceps muscles
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Muscle size
Assessed by calf circumference, measured in cm
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Body composition
Assessed by BIA
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Cognition
Abbreviated 14-item Cognitive Failure Questionnaire (CFQ-14), ranging from 0 to 56. A higher score indicates more cognitive errors.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Cognition
Montreal Cognitive Assessment (MoCA), ranging from 0 to 30. A higher score indicates better cognition.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Anxiety
Hospital Anxiety and Depression Scale (HADS), ranging from 0 to 42. Questions 1, 3, 5, 7, 9, 11 and 13 measure symptoms of anxiety (range: 0-21). Higher scores indicate worse symptoms of anxiety.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Depression
Hospital Anxiety and Depression Scale (HADS), ranging from 0 to 42. Questions 2, 4, 6, 8, 10, 12 and 14 measure symptoms of depression (range: 0-21). Higher scores indicate worse symptoms of depression.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Post-traumatic stress disorder
Trauma Screening Questionnaire (TSQ), ranging from 0 to 10. A higher score indicates worse symptoms of Post-Traumatic Stress Disorder.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Health-related Quality of Life
Short Form 36 (SF-36), ranging from 0 to 100. A higher score indicates a better Health-related Quality of Life.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Sleep quality
Pittsburgh Sleep Quality Index (PSQI), ranging from 0 to 21. Higher scores indicate worse sleep quality.
Measured: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Level of independence
Barthel index, ranging from 0-20. Higher scores indicate higher independence of the participant.
Measured: 4 times during cohort (ICU admission, 3-, 6- and 12-months post-ICU admission)
Frailty
Rockwood Clinical Frailty Scale (CFS), ranging from 1 to 9. A higher score indicates a more severe degree of frailty.
Measured: 5 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Dietary intake
24-hour recall, combined with a dietary food record.
Measured: 2 times during cohort (3-, and 12-months post-ICU admission)
Lipid metabolism
Plasma triglycerides, total cholesterol, HDL-cholesterol, and LDL-cholesterol levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Plasma glucose levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Plasma insulin levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Blood HbA1c levels
Measured: 3 times during cohort (at ICU admission, 3-, and 12-months post-ICU admission)
Protein metabolism
Plasma amino acid levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Thyroid hormones
Plasma thyroid hormone levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for kidney function
Plasma kidney function markers
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for liver function
Plasma liver function markers
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for muscle metabolism
Plasma muscle metabolism markers
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Micronutrient levels
Blood micronutrient levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Systemic inflammation markers
Plasma systemic inflammation marker levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Neuro-inflammation markers
Plasma neuro-inflammation marker levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal inflammation markers
Fecal intestinal inflammation marker levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Microbiota composition
Microbiota composition in feces (e.g., abundance, diversity and function)
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal fermentation markers
Fecal fermentation marker levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal integrity markers
Serum and plasma intestinal integrity marker levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA)
Plasma and fecal SCFA and BCFA concentrations
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Tryptophan metabolism
Plasma tryptophan metabolite levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Mean corpuscular volume
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Haemoglobin levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Haematocrit levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Leucocyte levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Thrombocyte levels
Measured: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start13 Oct 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Intensive Care Syndrome (PICS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARH van Zanten, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Global Research & Innovation Center, Wageningen University and Research, TKI Agri & Food
- Responsible party
- Sponsor-investigator, ARH van Zanten, MD PhD, Gelderse Vallei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170527
- Sponsor's protocol ID
- NL87540.091.24
- Acronym
- TOPICS
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07170527
- Acronym / sponsor ID
- TOPICS / NL87540.091.24
- Conditions
- Post-Intensive Care Syndrome (PICS)
- Keywords
- Post-Intensive Care Syndrome (PICS), Critical illness, Intensive Care Unit (ICU), Recovery, Long-Term Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ARH van Zanten, MD PhDUniversity, hospital or other
- Collaborators
- Danone Global Research & Innovation Center, Wageningen University and Research, TKI Agri & Food
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Yearly, more than 70.000 patients are admitted to the intensive care unit (ICU) in the Netherlands. Although survival rates from critical illness have improved over the last decades, still patients suffer from profound weakness and functional impairments, collectively referred to as post-intensive care syndrome (PICS). PICS encompasses a cluster of long-lasting physical, cognitive, and mental health problems that have a severe impact on patients' quality of life. Studies investigating strategies to improve recovery after critical illness have shown limited effectiveness. This might be due to heterogeneous recovery trajectories observed among ICU survivors. Research has focussed on the associations between non-modifiable factors (e.g., age, sex and disease severity) and PICS outcomes. However, comprehensive assessment of potentially modifiable metabolic signatures (such as hypercatabolism, muscle metabolism, nutritional status, inflammatory response, and gut health) is lacking. These modifiable factors might be of interest as these likely shape the recovery trajectory of critical illness survivors. This approach, by combining the assessment of nonmodifiable factors together with potentially modifiable factors, is essential for understandiing the complex, multifactorial, pathophysiological mechanisms underlying PICS.
The TOPICS study aims to explore the associations between modifiable factors during critical illness (such as hypercatabolism, muscle metabolism, nutritional status, inflammatory response, and gut health), and physical and psychological functioning in ICU survivors. The main questions it aims to answer are:
- What are the associations between metabolic signatures during the acute phase of critical illness and physical functioning 3-months post-ICU admission?
- What are the associations between metabolic signatures during the acute phase of critical illness and physical functioning across different time points in the recovery phase?
- What are the associations between metabolic signatures during the acute phase of critical illness and psychological functioning (cognitive functioning and mental health status) across different time points during the recovery phase?
- What is the trajectory of PICS outcomes, quality of life and metabolic parameters during one year following ICU admission?
- Can distinct patient phenotypes with different recovery trajectories be identified based on metabolic and physical functioning outcomes?
The study is a monocentre, longitudinal, explorative, prospective, observational study. Study measurements will be performed upon ICU admission, and in the recovery period (ICU discharge, 3-, 6-, and 12-months post-ICU admission). Study procedures include:
- Completion of questionnaires on health-related quality of life, cognitive functioning, mental health status, and sleep quality.
- Assessment of physical functioning.
- Collection of blood samples.
- Collection of fecal samples.
- Assessment of dietary intake.
The study population will consist of 200 adult patients admitted to the ICU of Gelderse Vallei Hospital, Ede, with an expected ICU length of stay of ≥72 hours, or who receive invasive mechanical ventila-tion (IMV) or non-invasive ventilation (NIV) within 48 hours after ICU admission and are ex-pected to receive this ventilatory support (IMV or NIV) for ≥48 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Adult patients with an expected ICU length of stay of ≥72 hours, or who receive (non-) invasive mechanical ventilation (IMV or NIV) within 48 hours after ICU admission with an expected ventilatory support duration of at least 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of 200 adult patients admitted to the ICU of Gelderse Vallei Hospital, Ede, with an expected ICU length of stay of ≥72 hours, or who receive invasive mechanical ventilation (IMV) or non-invasive ventilation (NIV) within 48 hours after ICU admission and are expected to receive this ventilatory support (IMV or NIV) for ≥48 hours.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective physical functioning
Time frame: 3-months post-ICU admission
Assessed by the Physical Component Score (PCS) of the Short Form-36 (SF-36) questionnaire, ranging from 0 to 100. Scores above or below the average of 50 indicate better or worse physical health compared to the general population, respectively.
Handgrip strength
Time frame: 3-months post-ICU admission
Assessed with Jamar dynamometer, measured in kilograms (kg).
Leg strength and endurance
Time frame: 3-months post-ICU admission
Assessed by the 30-second chair stand test (30sCST)
Muscle size
Time frame: 3-months post-ICU admission
Assessed by muscle ultrasound of the quadriceps muscles
Muscle size
Time frame: 3-months post-ICU admission
Assessed by calf circumference, measured in cm
Body composition
Time frame: 3-months post-ICU admission
Assessed by bio-electrical impedance analysis (BIA)
39 secondary outcomes
Subjective physical functioning
Time frame: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Handgrip strength
Time frame: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Leg strength and endurance
Time frame: 3 times during cohort (at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Muscle size
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Muscle size
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Body composition
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 6- and 12-months post-ICU admission)
Cognition
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Cognition
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Anxiety
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Depression
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Post-traumatic stress disorder
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Health-related Quality of Life
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Sleep quality
Time frame: 4 times during cohort (at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Level of independence
Time frame: 4 times during cohort (ICU admission, 3-, 6- and 12-months post-ICU admission)
Frailty
Time frame: 5 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, 6- and 12-months post-ICU admission)
Dietary intake
Time frame: 2 times during cohort (3-, and 12-months post-ICU admission)
Lipid metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Glucose metabolism
Time frame: 3 times during cohort (at ICU admission, 3-, and 12-months post-ICU admission)
Protein metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Thyroid hormones
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for kidney function
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for liver function
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Markers for muscle metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Micronutrient levels
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Systemic inflammation markers
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Neuro-inflammation markers
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal inflammation markers
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Microbiota composition
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal fermentation markers
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Intestinal integrity markers
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Short-chain fatty acids (SCFA) and branched-chain fatty acids (BCFA)
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Tryptophan metabolism
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Haematological health
Time frame: 4 times during cohort (at ICU admission, at ICU discharge (an average of 10 days), 3-, and 12-months post-ICU admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Intensive Care Syndrome (PICS), run by ARH van Zanten, MD PhD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arthur HR van Zanten, MD, PhD (+31318435964, zantena@zgv.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective physical functioning (time frame: 3-months post-ICU admission). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.