Clinical trial NCT04997915: Acute Kidney Injury in Coronavirus Disease-19 (COVID-19) Patients Admitted to the Intensive Care Unit (ICU)
Official title: Acute Kidney Injury in COVID-19 Patients Admitted to the ICU: a Multicenter Cohort Analysis in 9 Large Hospitals in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
COVID-19 Pneumonia
Acute Kidney Injury
Keywords: Acute kidney injury
COVID-19
ICU
Epidemiology
Kidney Replacement Therapy
Acute Kidney Disease
Recovery
Mortality
Survival
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: University Hospital, Antwerp
name: Ziekenhuis Oost-Limburg
name: Jessa Hospital
name: General Hospital Groeninge
name: AZ Delta
name: AZ Turnhout
name: AZ Sint-Jan AV
First posted: 2021-08-10
Enrollment: 1286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive Critical COVID-19 patients admitted to the ICU

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Kidney Injury (AKI)
timeFrame: up to day 21 of ICU admission
measure: Kidney outcome
timeFrame: day 30 after ICU admission
measure: Mortality
timeFrame: day 30 after ICU admission
measure: Survival
timeFrame: 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 outcomes:
measure: Acute Kidney Injury (AKI) creatinine criteria
timeFrame: up to day 21 of ICU admission
measure: Acute Kidney Injury (AKI) urine output criteria
timeFrame: up to day 21 of ICU admission
measure: Acute Kidney Injury (AKI), rapid reversal
timeFrame: up to day 21 of ICU admission
measure: Acute Kidney Disease (AKD)
timeFrame: up to day 21 of ICU admission
measure: AKI-Area Under the Curve (AUC)
timeFrame: up to day 21 of ICU admission
measure: Mortality AKD
timeFrame: day 30 after ICU admission
measure: Mortality AKI rapid reversal
timeFrame: day 30 after ICU admission
measure: Mortality AKI stage 2-3
timeFrame: day 30 after ICU admission
measure: Mortality AKI treated with KRT
timeFrame: day 30 after ICU admission
measure: Mortality AKI creatinine criteria versus urine output criteria versus full KDIGO
timeFrame: day 30 after ICU admission
measure: Mortality AKI-AUC
timeFrame: day 30 after ICU admission
measure: Kidney outcome AKI KDIGO creatinine or urine output
timeFrame: day 30 after ICU admission
measure: Duration of AKI and AKD
timeFrame: up to day 21 of ICU admission
measure: Survival AKI-AUC
timeFrame: 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
measure: Recovery of AKI and AKD
timeFrame: day 30 after ICU admission
measure: Timing of AKI, AKI severity grades and use of KRT
timeFrame: ICU admission up to day 21
measure: KRT modality
timeFrame: ICU admission up to day 21
measure: use of KRT
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: Mechanical Ventilation
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: Chronic Kidney Disease (CKD) (estimated glomerular filtration rate (eGFR)<60 mL/min)
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: elderly (>= 65 y)
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: obese (BMI>30 kg/m2)
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: prone ventilation
timeFrame: ICU admission up to day 21
measure: Subgroup analysis: extracorporeal membrane oxygenation (ECMO)
timeFrame: ICU admission up to day 21
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZ Antwerp
city: Brugge
country: Belgium
facility: AZ St-Jan AV
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: University Hospital, Ghent
name: Eric Hoste, Md, PhD
role: STUDY_CHAIR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Greet De Vlieger, Md, PhD
role: STUDY_CHAIR
References:
citation: Nadim MK, Forni LG, Mehta RL, Connor MJ Jr, Liu KD, Ostermann M, Rimmele T, Zarbock A, Bell S, Bihorac A, Cantaluppi V, Hoste E, Husain-Syed F, Germain MJ, Goldstein SL, Gupta S, Joannidis M, Kashani K, Koyner JL, Legrand M, Lumlertgul N, Mohan S, Pannu N, Peng Z, Perez-Fernandez XL, Pickkers P, Prowle J, Reis T, Srisawat N, Tolwani A, Vijayan A, Villa G, Yang L, Ronco C, Kellum JA. COVID-19-associated acute kidney injury: consensus report of the 25th Acute Disease Quality Initiative (ADQI) Workgroup. Nat Rev Nephrol. 2020 Dec;16(12):747-764. doi: 10.1038/s41581-020-00356-5. Epub 2020 Oct 15.
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citation: Hoste EA, Clermont G, Kersten A, Venkataraman R, Angus DC, De Bacquer D, Kellum JA. RIFLE criteria for acute kidney injury are associated with hospital mortality in critically ill patients: a cohort analysis. Crit Care. 2006;10(3):R73. doi: 10.1186/cc4915. Epub 2006 May 12.
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