Assessment of Kidney Function and Osteomuscular Status After Critical Care

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.

Study Overview

• Status: Suspended
• Conditions: Critical Illness; Bone Loss; Kidney Injury; Muscle Loss
• Intervention / Treatment: Other: one-year follow-up

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Belgium
  • Liège
    • Liège, Liège, Belgium, 4000
      • University Hospital of Liege

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

survivors of an ICU stay of at least 7 days

Description

Inclusion Criteria:

• patients surviving an ICU stay of at least 7 days
• patients who experienced acute kidney injury (KDIGO criteria) during ICU stay

Exclusion Criteria:

• chronic kidney injury with dedicated follow-up before ICU admission
• chronic extrarenal epuration
• kidney transplant
• allergy to iohexol
• iodinated contrast allergy
• refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-ICU group; Observational foolow-up	Other: one-year follow-up; patients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measured GFR	plasma clearance of iohexol	between day 0 and day 7 after ICU discharge
measured GFR	plasma clearance of iohexol	at 3 months after ICU discharge
measured GFR	plasma clearance of iohexol	at 12 months after ICU discharge
estimated GFR	cystatin C based CKD-EPI equation	between day 0 and day 7 after ICU discharge
estimated GFR	cystatin C based CKD-EPI equation	at 3 months after ICU discharge
estimated GFR	cystatin C based CKD-EPI equation	at 12 months after ICU discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine concentration of renal fibrose biomarkers	urine measurement of TGF-β concentration	between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of TGF-β concentration	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of TGF-β concentration	at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of monocyte chemoattractant protein-1 concentration	between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of monocyte chemoattractant protein-1 concentration	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of monocyte chemoattractant protein-1 concentration	at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of matrix metalloproteinases concentration	between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of matrix metalloproteinases concentration	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of matrix metalloproteinases concentration	at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of chemokine ligands concentration	between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of chemokine ligands concentration	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of chemokine ligands concentration	at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of C-X-C motif chemokine ligand concentration	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	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	urine measurement of C-X-C motif chemokine ligand concentration	at 12 months after ICU discharge
urine concentration of renal fibrose biomarkers	measurement of proteinuria	between day 0 and day 7 after ICU discharge
urine concentration of renal fibrose biomarkers	measurement of proteinuria	at 3 months after ICU discharge
urine concentration of renal fibrose biomarkers	measurement of proteinuria	at 12 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of myostatin concentration	between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers	blood measurement of myostatin concentration	at 3 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of myostatin concentration	at 12 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of procollagen type III N-terminal peptide (P3NP) concentration	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	at 3 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of procollagen type III N-terminal peptide (P3NP) concentration	at 12 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of insulin growth factor 1 concentration	between day 0 and day 7 after ICU discharge
blood concentration of muscle turnover markers	blood measurement of insulin growth factor 1 concentration	at 3 months after ICU discharge
blood concentration of muscle turnover markers	blood measurement of insulin growth factor 1 concentration	at 12 months after ICU discharge
bone micro-architecture	high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition	between day 0 and day 7 after ICU discharge
bone micro-architecture	high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition	at 3 months after ICU discharge
bone micro-architecture	high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition	at 12 months after ICU discharge

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liege

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 9, 2021
• First Submitted That Met QC Criteria: July 17, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 26, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Disease Attributes; Metabolic Diseases; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Critical Illness; Muscular Atrophy; Bone Diseases, Metabolic
• Other Study ID Numbers: ROPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No