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Clinical Trials/NCT04980092
NCT04980092
Suspended
Not Applicable

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

University of Liege1 site in 1 country100 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University of Liege
Enrollment
100
Locations
1
Primary Endpoint
measured GFR
Status
Suspended
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
January 1, 2027
Last Updated
4 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anne-Françoise Rousseau

Head of Clinic

University of Liege

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

Outcomes

Primary Outcomes

measured GFR

Time Frame: at 12 months after ICU discharge

plasma clearance of iohexol

estimated GFR

Time Frame: at 12 months after ICU discharge

cystatin C based CKD-EPI equation

Secondary Outcomes

  • urine concentration of renal fibrose biomarkers(at 12 months after ICU discharge)
  • blood concentration of muscle turnover markers(at 12 months after ICU discharge)
  • bone micro-architecture(at 12 months after ICU discharge)

Study Sites (1)

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