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

NCT ID: NCT04459975

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-11-30

Brief Summary

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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

Detailed Description

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Conditions

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on Occurrence of Acurate Kidney Injury During Intensive Care Unit Abnormalities of Urinary Analysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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AKI (-)

patients treated in ICU for COVID-19 infection and without occurrence of AKI (define as creatinine \> 1,5x baseline according with KDIGO guidelines)

No interventions assigned to this group

AKI (+)

patient treated in ICU for COVID-19 infection and with occurrence of AKI among which:

• Severe AKI patients (define as creatinine \> 3x baseline or need for renal replacement therapy according with KDIGO guidelines) who will participate to biocollection and to post-mortem biopsy (if death).

Non interventional study

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intensive care units attached to the Hospices Civils de Lyon (HCL)

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Denis FOUQUE, Professor

Role: CONTACT

+33 472 678 704

Maxime ESPI

Role: CONTACT

+33 472 678 704

Facility Contacts

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Denis FOUQUE, Professor

Role: primary

+33 472 678 704

Maxime EPSI

Role: backup

+33 472 678 704

Other Identifiers

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CoV-AKI_2020

Identifier Type: -

Identifier Source: org_study_id

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