Assessment of Kidney Function and Osteomuscular Status After Critical Care

NCT04980092 | Suspended

• 1 other identifier: ROPS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Kidney Injury; Muscle Loss; Bone Loss

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (30)

• urine concentration of renal fibrose biomarkers

  between day 0 and day 7 after ICU discharge

• urine concentration of renal fibrose biomarkers

  at 3 months after ICU discharge

• urine concentration of renal fibrose biomarkers

  at 12 months after ICU discharge

• urine concentration of renal fibrose biomarkers

  between day 0 and day 7 after ICU discharge

• urine concentration of renal fibrose biomarkers

  at 3 months after ICU discharge

Study Arms (1)

Post-ICU group

Observational foolow-up

Other: one-year follow-up

Interventions

one-year follow-up OTHER

patients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health

Post-ICU group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

survivors of an ICU stay of at least 7 days

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

University Hospital of Liège

Liège, Liège, 4000, Belgium

Location

MeSH Terms

Conditions

Critical Illness; Muscular Atrophy; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anne-Françoise Rousseau, MD, PhD

  University hospital of Liège

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: July 28, 2021
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

BE (1)