Urinary Biomarkers for AKI Diagnosis in Patients With SARS-CoV-2 (COVID-19)

Completed

• Conditions: Renal Replacement Therapy; Acute Kidney Injury; COVID-19
• Interventions: Other: [TIMP-2]*[IGFBP-7]

• Registration Number: NCT04393428
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Among patients with SARS-CoV-2 pneumonia, approximately 20% have an acute kidney injury (AKI) and 5% require renal replacement therapy. Occurrence of AKI in patients with COVID-19 is associated with increased morbidity and mortality. Early detection of patients at risk of AKI would allow to prevent onset or worsening of AKI. The aim of this study is to determine if urine biomarkers of renal tubular damage such as TIMP-2 and IGFBP7 could early identify patients with SARS-CoV-2 pneumonia at risk of developing AKI.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-19
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients with urinary samples	[TIMP-2]*[IGFBP-7]	COVID-19 patients with urinary samples

Primary Outcome Measures

Name	Time	Method
Sensibility and specificity of urinary	Occurence of AKI 7 days after urinary biomarkers measurement	Sensibility and specificity of urinary \[TIMP-2\]\*\[IGFBP-7\] \> 0,3 to predict AKI (KDIGO stage ≥ 1) in SARS-CoV-2 patients at day-7 after measurement

Secondary Outcome Measures

Name	Time	Method
Sensibility and specificity of urinary	Occurnce of AKI worsening, renal replacement therapy requirement or persistant AKI, 7 days after urinary biomarkers mesurement	Sensibility and specificity of urinary \[TIMP-2\]\*\[IGFBP-7\] \> 0,3 to predict AKI worsening, renal replacement therapy requirement or persistant AKI

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France