Acute Kidney Injury in Coronavirus Disease-19 (COVID-19) Patients Admitted to the Intensive Care Unit (ICU)

Study Overview
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Brief Summary
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The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT.

Detailed Description
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The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT. This will be a cohort analysis of the rate of COVID-19 associated AKI and KRT during the period 1 February 2020 - 31 January 2021 in 6 large hospitals in Flanders Belgium and 3 Flemish University Hospitals. We will collect patients' baseline characteristics, specific treatment for COVID-19, other relevant therapies and severity of illness and ICU and hospital outcome data. AKI will be assessed during ICU stay up to 21 days of ICU stay, and will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition. In addition, we will assess occurrence of AKI stages, duration of AKI, duration of AKI integrated with severity stage of AKI into the area under the curve of AKI, occurrence of rapid reversal of AKI, occurrence of Acute Kidney Disease (AKD) defined according to KDIGO.

Official Title
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Acute Kidney Injury in COVID-19 Patients Admitted to the ICU: a Multicenter Cohort Analysis in 9 Large Hospitals in Belgium

Conditions
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Critical Illness, COVID-19 Pneumonia, Acute Kidney Injury

Intervention / Treatment
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* Other: Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2) infection confirmed by Polymerase Chain Reaction (PCR) on nasopharyngeal swab or oropharyngeal swab or rectal swab or bronchoalveolar aspirate admission to the ICU for monitoring or organ support Exclusion Criteria: asymptomatic COVID-19 patients admitted to the ICU for medical reason not related to COVID-19

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critical COVID-19<br>Critical COVID-19 patients admitted to the ICU | Other: Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU<br>* Critical COVID-19 patients admitted to the ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) | AKI occurrence and severity stages defined according to KDIGO | up to day 21 of ICU admission | 
| Kidney outcome | use of KRT and eGFR in patients without AKI (no AKI), AKI, and AKI stages | day 30 after ICU admission | 
| Mortality | Mortality of AKI and no AKI patients will be compared | day 30 after ICU admission | 
| Survival | Survival of no AKI, AKI and AKI stages, AKD, and rapid reversal up to day 30 or hospital discharge whichever comes last | AKI and AKD will be classified up to day 21 of ICU stay, and survival will be assessed up to day 30 or hospital discharge whichever is last | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) creatinine criteria | AKI occurrence and severity stages defined according to KDIGO creatinine criteria | up to day 21 of ICU admission | 
| Acute Kidney Injury (AKI) urine output criteria | AKI occurrence and severity stages defined according to KDIGO urine output criteria | up to day 21 of ICU admission | 
| Acute Kidney Injury (AKI), rapid reversal | Occurrence of AKI for 48-h or less | up to day 21 of ICU admission | 
| Acute Kidney Disease (AKD) | Occurrence and severity staging of AKD according to KDIGO criteria | up to day 21 of ICU admission | 
| AKI-Area Under the Curve (AUC) | Assessment of AKI-AUC which is defined as the sum of the daily maximum severity stage of AKI | up to day 21 of ICU admission | 
| Mortality AKD | Mortality of patients with AKD and severity stages of AKD will be compared to no AKI and patients with AKI and different AKI stages | day 30 after ICU admission | 
| Mortality AKI rapid reversal | Mortality of patients with AKI rapid reversal ill be compared to no AKI and patients with AKI and different AKI stages | day 30 after ICU admission | 
| Mortality AKI stage 2-3 | Mortality of patients with AKI stage 2 or greater and patients with no AKI or AKI stage 1 will be compared | day 30 after ICU admission | 
| Mortality AKI treated with KRT | Mortality of patients with AKI treated with KRT and patients with no AKI or AKI stage 1, 2 or 3 will be compared | day 30 after ICU admission | 
| Mortality AKI creatinine criteria versus urine output criteria versus full KDIGO | Mortality of patients with AKI and patients with no AKI will be compared | day 30 after ICU admission | 
| Mortality AKI-AUC | Mortality of quartiles of AKI-AUC will be assessed | day 30 after ICU admission | 
| Kidney outcome AKI KDIGO creatinine or urine output | use of KRT and eGFR in no AKI, AKI on creatinine or urine output criteria and AKI stages, Rapid Reversal of AKI, and AKD and stages | day 30 after ICU admission | 
| Duration of AKI and AKD | Duration of AKI, AKI on creatinine or urine output criteria and AKI stages, Rapid Reversal of AKI, and AKD and stages | up to day 21 of ICU admission | 
| Survival AKI-AUC | Survival up to day 30 or hospital discharge (whichever is last) for quartiles of AKI-AUC will be assessed | AKI-AUC will be assessed up to day 21 of ICU stay, and survival will be assessed up to day 30 or hospital discharge whichever is last | 
| Recovery of AKI and AKD | Recovery of AKI, AKI stages, AKD and AKD stages, KRT will be assessed | day 30 after ICU admission | 
| Timing of AKI, AKI severity grades and use of KRT | timing of occurrence of AKI in relation to onset of symptoms, hospital admission, ICU admission | ICU admission up to day 21 | 
| KRT modality | initial modality of KRT and anticoagulation used | ICU admission up to day 21 | 
| use of KRT | number of KRT treatment days, and KRT free days | ICU admission up to day 21 | 
| Subgroup analysis: Mechanical Ventilation | outcomes will be assessed in patients with and without mechanical ventilation at time of start of AKI | ICU admission up to day 21 | 
| Subgroup analysis: Chronic Kidney Disease (CKD) (estimated glomerular filtration rate (eGFR)<60 mL/min) | outcomes will be assessed in patients with and without CKD as baseline kidney function | ICU admission up to day 21 | 
| Subgroup analysis: elderly (>= 65 y) | outcomes will be assessed in patients older and younger than 65y | ICU admission up to day 21 | 
| Subgroup analysis: obese (BMI>30 kg/m2) | outcomes will be assessed in obese patients and non-obese | ICU admission up to day 21 | 
| Subgroup analysis: prone ventilation | outcomes will be assessed in patients treated with mechanical ventilation and in prone position | ICU admission up to day 21 | 
| Subgroup analysis: extracorporeal membrane oxygenation (ECMO) | outcomes will be assessed in patients treated with ECMO | ICU admission up to day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute kidney injury, COVID-19, ICU, Epidemiology, Kidney Replacement Therapy, Acute Kidney Disease, Recovery, Mortality, Survival