Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

Abnormalities of Urinary Analysis Clinical Trial

Official title:

Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459975
• Other study ID #: CoV-AKI_2020
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: November 2020

Study information

• Verified date: July 2020
• Source: Hospices Civils de Lyon
• Contact: Denis FOUQUE, Professor
• Phone: +33 472 678 704
• Email: denis.fouque[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The actual COVID-19 epidemy is an unprecedented healthcare problem. Although acute respiratory distress syndrome is the main organ failure, acute kidney injury (AKI) has appeared to be more frequent and more severe than expected. Some data suggested a potential direct renal tropism of the virus, or undirect injury by "cytokine storm".

The aims of this study are:

1. To describe incidence, severity and mortality associated with AKI during covid-19 infection in ICU

2. To identify specific risk factors for AKI

3. To explore pathophysiologic mechanism of AKI during COVID-19 infection

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed COVID-19 infection (by qRT-PCR and/or TDM typical lesion)

• Needing intensive care

Exclusion Criteria:

• End Stage Renal Disease patients (with pre-existent dialysis)

• Intensive care support for less than 72h (transfer in conventional unit or death)

Related Conditions & MeSH terms

• Abnormalities of Urinary Analysis
• Acute Kidney Injury
• on Occurrence of Acurate Kidney Injury During Intensive Care Unit
• Wounds and Injuries

Intervention

Other:
• Non interventional study
Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient. Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis

Locations

Country	Name	City	State
France	Intensive care units attached to the Hospices Civils de Lyon (HCL)	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection	AKI will be defined according with KDIGO guidelines: increase in creatinine of more than 1,5 fold compared to baseline Severe CVOID-19 infection is defined as 1/ confirm COVID-19 infection (by TDM and/or qRT-PCR) 2/ Requirement of ICU support during more than 72h	7 months