Critical IllnessNCT04980092
Assessment of Kidney Function and Osteomuscular Status After Critical Care
An observational study of Critical Illness and Kidney Injury, run by University of Liege at 1 site in Belgium.
Trial summary
This observational study aims to assess kidney function through direct glomerular filtration rate (GFR) using iohexol clearance, compared to estimated GFR based on creatinine and cystatin C equations. Kidney function will also be evaluated through renal fibrosis biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Kidney Injury, Muscle Loss
- What is being tested?
- one-year follow-up
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2023to Jan 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
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: survivors of an ICU stay of at least 7 days
Who may be able to join
- patients surviving an ICU stay of at least 7 days
- patients who experienced acute kidney injury (KDIGO criteria) during ICU stay
Who cannot join
- chronic kidney injury with dedicated follow-up before ICU admission
- chronic extrarenal epuration
- kidney transplant
- allergy to iohexol
- iodinated contrast allergy
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Kidney Function and Osteomuscular Status in Survivors of a Prolonged Stay in Intensive Care Unit
This observational study aims to assess kidney function through direct glomerular filtration rate (GFR) using iohexol clearance, compared to estimated GFR based on creatinine and cystatin C equations. Kidney function will also be evaluated through renal fibrosis biomarkers. Kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.
Read the detailed description
The investigators developed a post-ICU clinic where complications of the post-intensive care syndrome are detected. Muscle function is assessed by clinical testings, muscle strength measurement. Body composition is measured by electrical bioimpedance. Bone mass is assessed using dual-energy radiographic absorptiometry.
It is well known that ICU survivors experience a loss of muscle mass. This can lead to misinterpretation of estimated GFR based on creatinine equations.
The aim of the present study is to assess the evolution of kidney function after a prolonged stay in ICU, using GFR equations based on cystatin C, and to compare it to measured GFR using iohexol clearance.
The second aim is to explore the evolution of bone and muscle health in these patients.
- Conditions
- Critical Illness, Kidney Injury, Muscle Loss, Bone Loss
- Being tested
- one-year follow-up
- Medical subject headings
- Critical Illness, Muscular Atrophy, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-year follow-upOther
patients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health
| Study group | Role | What they receive |
|---|---|---|
| Post-ICU group | Observational foolow-up Receives: Other: one-year follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
measured GFR
plasma clearance of iohexol
Measured: between day 0 and day 7 after ICU discharge
measured GFR
plasma clearance of iohexol
Measured: at 3 months after ICU discharge
measured GFR
plasma clearance of iohexol
Measured: at 12 months after ICU discharge
estimated GFR
cystatin C based CKD-EPI equation
Measured: between day 0 and day 7 after ICU discharge
estimated GFR
cystatin C based CKD-EPI equation
Measured: at 3 months after ICU discharge
estimated GFR
cystatin C based CKD-EPI equation
Measured: at 12 months after ICU discharge
Secondary outcomes (30)
urine concentration of renal fibrose biomarkers
urine measurement of TGF-β concentration
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of TGF-β concentration
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of TGF-β concentration
Measured: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of monocyte chemoattractant protein-1 concentration
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of monocyte chemoattractant protein-1 concentration
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of monocyte chemoattractant protein-1 concentration
Measured: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of matrix metalloproteinases concentration
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of matrix metalloproteinases concentration
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of matrix metalloproteinases concentration
Measured: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of chemokine ligands concentration
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of chemokine ligands concentration
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of chemokine ligands concentration
Measured: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of C-X-C motif chemokine ligand concentration
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of C-X-C motif chemokine ligand concentration
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
urine measurement of C-X-C motif chemokine ligand concentration
Measured: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
measurement of proteinuria
Measured: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
measurement of proteinuria
Measured: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
measurement of proteinuria
Measured: at 12 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of myostatin concentration
Measured: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
blood measurement of myostatin concentration
Measured: at 3 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of myostatin concentration
Measured: at 12 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of procollagen type III N-terminal peptide (P3NP) concentration
Measured: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
blood measurement of procollagen type III N-terminal peptide (P3NP) concentration
Measured: at 3 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of procollagen type III N-terminal peptide (P3NP) concentration
Measured: at 12 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of insulin growth factor 1 concentration
Measured: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
blood measurement of insulin growth factor 1 concentration
Measured: at 3 months after ICU discharge
blood concentration of muscle turnover markers
blood measurement of insulin growth factor 1 concentration
Measured: at 12 months after ICU discharge
bone micro-architecture
high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition
Measured: between day 0 and day 7 after ICU discharge
bone micro-architecture
high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition
Measured: at 3 months after ICU discharge
bone micro-architecture
high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition
Measured: at 12 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Mar 2023
- Primary completionMar 2026 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Enrollment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Françoise Rousseau, University of Liege
- Investigators
- Anne-Françoise Rousseau, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980092
- Sponsor's protocol ID
- ROPS
- Status last verified
- Dec 2025
- First submitted
- 9 Jul 2021
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Kidney Function and Osteomuscular Status in Survivors of a Prolonged Stay in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04980092
- Acronym / sponsor ID
- ROPS
- Conditions
- Critical Illness, Kidney Injury, Muscle Loss, Bone Loss
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Enrollment difficulties
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 28 Jul 2021 (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.
This observational study aims to assess kidney function through direct glomerular filtration rate (GFR) using iohexol clearance, compared to estimated GFR based on creatinine and cystatin C equations. Kidney function will also be evaluated through renal fibrosis biomarkers. Kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.
Detailed description
The investigators developed a post-ICU clinic where complications of the post-intensive care syndrome are detected. Muscle function is assessed by clinical testings, muscle strength measurement. Body composition is measured by electrical bioimpedance. Bone mass is assessed using dual-energy radiographic absorptiometry.
It is well known that ICU survivors experience a loss of muscle mass. This can lead to misinterpretation of estimated GFR based on creatinine equations.
The aim of the present study is to assess the evolution of kidney function after a prolonged stay in ICU, using GFR equations based on cystatin C, and to compare it to measured GFR using iohexol clearance.
The second aim is to explore the evolution of bone and muscle health in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-ICU group | – | Other: one-year follow-upObservational foolow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- survivors of an ICU stay of at least 7 days
Key inclusion criteria (2 listed)
- patients surviving an ICU stay of at least 7 days
- patients who experienced acute kidney injury (KDIGO criteria) during ICU stay
Key exclusion criteria (6 listed)
- chronic kidney injury with dedicated follow-up before ICU admission
- chronic extrarenal epuration
- kidney transplant
- allergy to iohexol
- iodinated contrast allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one-year follow-uppatients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health | Other | Post-ICU group |
Primary outcome
measured GFR
Time frame: between day 0 and day 7 after ICU discharge
plasma clearance of iohexol
measured GFR
Time frame: at 3 months after ICU discharge
plasma clearance of iohexol
measured GFR
Time frame: at 12 months after ICU discharge
plasma clearance of iohexol
estimated GFR
Time frame: between day 0 and day 7 after ICU discharge
cystatin C based CKD-EPI equation
estimated GFR
Time frame: at 3 months after ICU discharge
cystatin C based CKD-EPI equation
estimated GFR
Time frame: at 12 months after ICU discharge
cystatin C based CKD-EPI equation
30 secondary outcomes
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers
Time frame: at 12 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 3 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 12 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 3 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 12 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 3 months after ICU discharge
blood concentration of muscle turnover markers
Time frame: at 12 months after ICU discharge
bone micro-architecture
Time frame: between day 0 and day 7 after ICU discharge
bone micro-architecture
Time frame: at 3 months after ICU discharge
bone micro-architecture
Time frame: at 12 months after ICU discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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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. This study is not recruiting at the moment.
Anne-Françoise Rousseau, MD, PhD principal investigator
Centre Hospitalier Universitaire de Liege
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 Critical Illness and Kidney Injury, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 6 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: paused, as of the sponsor's last update on 31 Dec 2025. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measured GFR (time frame: between day 0 and day 7 after ICU discharge). 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 31 Dec 2025.