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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459975
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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

Condition or disease Intervention/treatment
on Occurrence of Acurate Kidney Injury During Intensive Care Unit Abnormalities of Urinary Analysis Other: Non interventional study

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Acute Kidney Injury and Renal Outcomes for COVID-19 Patients in Intensive Care Units
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

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

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





Primary Outcome Measures :
  1. Primary endpoint is the incidence, the severity and the mortality associated with AKI during COVID-19 severe infection [ Time Frame: 7 months ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients supported in intensive care units for covid-19 infection
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459975


Contacts
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Contact: Denis FOUQUE, Professor +33 472 678 704 denis.fouque@chu-lyon.fr
Contact: Maxime ESPI +33 472 678 704 maxime.espi@chu-lyon.fr

Locations
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France
Intensive care units attached to the Hospices Civils de Lyon (HCL) Recruiting
Lyon, France, 69002
Contact: Denis FOUQUE, Professor    +33 472 678 704    denis.fouque@chu-lyon.fr   
Contact: Maxime EPSI    +33 472 678 704    maxime.espi@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04459975    
Other Study ID Numbers: CoV-AKI_2020
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Acurate Kidney Injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases