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NCT04980092 Clinical Trial

Assessment of Kidney Function and Osteomuscular Status After Critical Care

Critical Illness Clinical Trial

Official title:
Assessment of Kidney Function and Osteomuscular Status in Survivors of a Prolonged Stay in Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04980092
Other study ID # ROPS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date January 2027

Study information
Verified date June 2023
Source University of Liege
Contact Anne-Françoise Rousseau, MD, PhD
Phone +3243667495
Email afrousseau@chuliege.be
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. Kidney function will be correlated to body composition, muscle turnover biomarkers, and bone micro-architecture.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date January 2027
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium University Hospital of Liège Liège

Sponsors (1)
Lead Sponsor Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary measured GFR plasma clearance of iohexol between day 0 and day 7 after ICU discharge
Primary measured GFR plasma clearance of iohexol at 3 months after ICU discharge
Primary measured GFR plasma clearance of iohexol at 12 months after ICU discharge
Primary estimated GFR cystatin C based CKD-EPI equation between day 0 and day 7 after ICU discharge
Primary estimated GFR cystatin C based CKD-EPI equation at 3 months after ICU discharge
Primary estimated GFR cystatin C based CKD-EPI equation at 12 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of TGF-ß concentration between day 0 and day 7 after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of TGF-ß concentration at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of TGF-ß concentration at 12 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of monocyte chemoattractant protein-1 concentration between day 0 and day 7 after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of monocyte chemoattractant protein-1 concentration at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of monocyte chemoattractant protein-1 concentration at 12 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of matrix metalloproteinases concentration between day 0 and day 7 after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of matrix metalloproteinases concentration at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of matrix metalloproteinases concentration at 12 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of chemokine ligands concentration between day 0 and day 7 after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of chemokine ligands concentration at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of chemokine ligands concentration at 12 months after ICU discharge
Secondary 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
Secondary urine concentration of renal fibrose biomarkers urine measurement of C-X-C motif chemokine ligand concentration at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers urine measurement of C-X-C motif chemokine ligand concentration at 12 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers measurement of proteinuria between day 0 and day 7 after ICU discharge
Secondary urine concentration of renal fibrose biomarkers measurement of proteinuria at 3 months after ICU discharge
Secondary urine concentration of renal fibrose biomarkers measurement of proteinuria at 12 months after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of myostatin concentration between day 0 and day 7 after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of myostatin concentration at 3 months after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of myostatin concentration at 12 months after ICU discharge
Secondary 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
Secondary blood concentration of muscle turnover markers blood measurement of procollagen type III N-terminal peptide (P3NP) concentration at 3 months after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of procollagen type III N-terminal peptide (P3NP) concentration at 12 months after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of insulin growth factor 1 concentration between day 0 and day 7 after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of insulin growth factor 1 concentration at 3 months after ICU discharge
Secondary blood concentration of muscle turnover markers blood measurement of insulin growth factor 1 concentration at 12 months after ICU discharge
Secondary bone micro-architecture high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition between day 0 and day 7 after ICU discharge
Secondary bone micro-architecture high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition at 3 months after ICU discharge
Secondary bone micro-architecture high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition at 12 months after ICU discharge
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