Clinical trial NCT04980092: Assessment of Kidney Function and Osteomuscular Status After Critical Care
Official title: Assessment of Kidney Function and Osteomuscular Status in Survivors of a Prolonged Stay in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Kidney Injury
Muscle Loss
Bone Loss
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: survivors of an ICU stay of at least 7 days

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: measured GFR
timeFrame: between day 0 and day 7 after ICU discharge
measure: measured GFR
timeFrame: at 3 months after ICU discharge
measure: measured GFR
timeFrame: at 12 months after ICU discharge
measure: estimated GFR
timeFrame: between day 0 and day 7 after ICU discharge
measure: estimated GFR
timeFrame: at 3 months after ICU discharge
measure: estimated GFR
timeFrame: at 12 months after ICU discharge
Secondary outcomes:
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: between day 0 and day 7 after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 3 months after ICU discharge
measure: urine concentration of renal fibrose biomarkers
timeFrame: at 12 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: between day 0 and day 7 after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 3 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 12 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: between day 0 and day 7 after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 3 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 12 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: between day 0 and day 7 after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 3 months after ICU discharge
measure: blood concentration of muscle turnover markers
timeFrame: at 12 months after ICU discharge
measure: bone micro-architecture
timeFrame: between day 0 and day 7 after ICU discharge
measure: bone micro-architecture
timeFrame: at 3 months after ICU discharge
measure: bone micro-architecture
timeFrame: at 12 months after ICU discharge
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
affiliation: University hospital of Liège
name: Anne-Françoise Rousseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: