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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| University Hospital, Antwerp | OTHER |
| Ziekenhuis Oost-Limburg | OTHER |
| Jessa Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical COVID-19 | Critical COVID-19 patients admitted to the ICU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU | Other | Critical COVID-19 patients admitted to the ICU |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All consecutive Critical COVID-19 patients admitted to the ICU
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hoste, Md, PhD | University Hospital, Ghent | Study Chair |
| Greet De Vlieger, Md, PhD | Universitaire Ziekenhuizen KU Leuven | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerp | Antwerp | 2650 | Belgium | |||
| AZ St-Jan AV |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33060844 | Background | 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. | |
| 32777758 |
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Investigators may propose additional analyses on the dataset. These proposals will be evaluated by the 2 study chairs Eric Hoste and Greet De Vlieger and the study group for eligibility
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| OTHER |
| General Hospital Groeninge | OTHER |
| AZ Delta | OTHER |
| AZ Turnhout | OTHER |
| AZ Sint-Jan AV | OTHER |
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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 |
| Bruges |
| 8000 |
| Belgium |
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| AZ Groeninge | Kortrijk | 8500 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| AZ Turnhout | Turnhout | 2300 | Belgium |
| Background |
| Ostermann M, Lumlertgul N, Forni LG, Hoste E. What every Intensivist should know about COVID-19 associated acute kidney injury. J Crit Care. 2020 Dec;60:91-95. doi: 10.1016/j.jcrc.2020.07.023. Epub 2020 Jul 28. |
| 28239173 | Background | Chawla LS, Bellomo R, Bihorac A, Goldstein SL, Siew ED, Bagshaw SM, Bittleman D, Cruz D, Endre Z, Fitzgerald RL, Forni L, Kane-Gill SL, Hoste E, Koyner J, Liu KD, Macedo E, Mehta R, Murray P, Nadim M, Ostermann M, Palevsky PM, Pannu N, Rosner M, Wald R, Zarbock A, Ronco C, Kellum JA; Acute Disease Quality Initiative Workgroup 16.. Acute kidney disease and renal recovery: consensus report of the Acute Disease Quality Initiative (ADQI) 16 Workgroup. Nat Rev Nephrol. 2017 Apr;13(4):241-257. doi: 10.1038/nrneph.2017.2. Epub 2017 Feb 27. |
| 34252450 | Background | Lameire NH, Levin A, Kellum JA, Cheung M, Jadoul M, Winkelmayer WC, Stevens PE; Conference Participants. Harmonizing acute and chronic kidney disease definition and classification: report of a Kidney Disease: Improving Global Outcomes (KDIGO) Consensus Conference. Kidney Int. 2021 Sep;100(3):516-526. doi: 10.1016/j.kint.2021.06.028. Epub 2021 Jul 9. |
| 32709292 | Background | Ostermann M, Bellomo R, Burdmann EA, Doi K, Endre ZH, Goldstein SL, Kane-Gill SL, Liu KD, Prowle JR, Shaw AD, Srisawat N, Cheung M, Jadoul M, Winkelmayer WC, Kellum JA; Conference Participants. Controversies in acute kidney injury: conclusions from a Kidney Disease: Improving Global Outcomes (KDIGO) Conference. Kidney Int. 2020 Aug;98(2):294-309. doi: 10.1016/j.kint.2020.04.020. Epub 2020 Apr 26. |
| 16696865 | Background | 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. |
| 35879765 | Derived | Schaubroeck H, Vandenberghe W, Boer W, Boonen E, Dewulf B, Bourgeois C, Dubois J, Dumoulin A, Fivez T, Gunst J, Hermans G, Lormans P, Meersseman P, Mesotten D, Stessel B, Vanhoof M, De Vlieger G, Hoste E. Acute kidney injury in critical COVID-19: a multicenter cohort analysis in seven large hospitals in Belgium. Crit Care. 2022 Jul 25;26(1):225. doi: 10.1186/s13054-022-04086-x. |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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