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

Critical Illness Clinical Trial

— COVID-AKI-B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04997915
• Other study ID #: BC-08285
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: May 17, 2022

Study information

• Verified date: January 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1286
• Est. completion date: May 17, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• COVID-19
• COVID-19 Pneumonia
• Critical Illness
• Wounds and Injuries

Intervention

Other:
• Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU
Critical COVID-19 patients admitted to the ICU

Locations

Country	Name	City	State
Belgium	UZ Antwerp	Antwerp
Belgium	AZ St-Jan AV	Brugge
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Ghent University Hospital	Ghent
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven	Leuven
Belgium	AZ Delta	Roeselare
Belgium	AZ Turnhout	Turnhout

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital, Ghent	AZ Delta, AZ Sint-Jan AV, AZ Turnhout, General Hospital Groeninge, Jessa Hospital, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View 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. Epub 2006 May 12. — View Citation

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. — View Citation

Nadim MK, Forni LG, Mehta RL, Connor MJ Jr, Liu KD, Ostermann M, Rimmelé 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. Review. Erratum in: Nat Rev Nephrol. 2020 Nov 2;:. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury (AKI)	AKI occurrence and severity stages defined according to KDIGO	up to day 21 of ICU admission
Primary	Kidney outcome	use of KRT and eGFR in patients without AKI (no AKI), AKI, and AKI stages	day 30 after ICU admission
Primary	Mortality	Mortality of AKI and no AKI patients will be compared	day 30 after ICU admission
Primary	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	Acute Kidney Injury (AKI) creatinine criteria	AKI occurrence and severity stages defined according to KDIGO creatinine criteria	up to day 21 of ICU admission
Secondary	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
Secondary	Acute Kidney Injury (AKI), rapid reversal	Occurrence of AKI for 48-h or less	up to day 21 of ICU admission
Secondary	Acute Kidney Disease (AKD)	Occurrence and severity staging of AKD according to KDIGO criteria	up to day 21 of ICU admission
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality AKI-AUC	Mortality of quartiles of AKI-AUC will be assessed	day 30 after ICU admission
Secondary	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
Secondary	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
Secondary	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
Secondary	Recovery of AKI and AKD	Recovery of AKI, AKI stages, AKD and AKD stages, KRT will be assessed	day 30 after ICU admission
Secondary	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
Secondary	KRT modality	initial modality of KRT and anticoagulation used	ICU admission up to day 21
Secondary	use of KRT	number of KRT treatment days, and KRT free days	ICU admission up to day 21
Secondary	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
Secondary	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
Secondary	Subgroup analysis: elderly (>= 65 y)	outcomes will be assessed in patients older and younger than 65y	ICU admission up to day 21
Secondary	Subgroup analysis: obese (BMI>30 kg/m2)	outcomes will be assessed in obese patients and non-obese	ICU admission up to day 21
Secondary	Subgroup analysis: prone ventilation	outcomes will be assessed in patients treated with mechanical ventilation and in prone position	ICU admission up to day 21
Secondary	Subgroup analysis: extracorporeal membrane oxygenation (ECMO)	outcomes will be assessed in patients treated with ECMO	ICU admission up to day 21