Assessment of Kidney Function and Osteomuscular Status After Critical Care

Recruiting

• Conditions: Kidney Injury; Critical Illness; Muscle Loss; Bone Loss
• Interventions: Other: one-year follow-up

• Registration Number: NCT04980092
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2021-07-09
• Study First Submitted QC: 2021-07-17
• Study First Posted: 2021-07-28
• Study Start: 2023-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-25
• Last Update Posted: 2023-06-27
• Primary Completion: 2026-03
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post-ICU group	one-year follow-up	Observational foolow-up

Primary Outcome Measures

Name	Time	Method
measured GFR	at 12 months after ICU discharge	plasma clearance of iohexol
estimated GFR	at 12 months after ICU discharge	cystatin C based CKD-EPI equation

Secondary Outcome Measures

Name	Time	Method
urine concentration of renal fibrose biomarkers	at 12 months after ICU discharge	measurement of proteinuria
blood concentration of muscle turnover markers	at 12 months after ICU discharge	blood measurement of insulin growth factor 1 concentration
bone micro-architecture	at 12 months after ICU discharge	high resolution peripheral quantitative computed tomography (HRpQCT) images acquisition

Trial Locations

Locations (1)

University Hospital of Liège; 🇧🇪 Liège, Belgium