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

NCT04997915 | Completed DMC

• 1 other identifier: BC-08285
• Study Type: observational
• Target: 1,286
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (24)

• Acute Kidney Injury (AKI) creatinine criteria

  up to day 21 of ICU admission

• Acute Kidney Injury (AKI) urine output criteria

  up to day 21 of ICU admission

• Acute Kidney Injury (AKI), rapid reversal

  up to day 21 of ICU admission

• Acute Kidney Disease (AKD)

  up to day 21 of ICU admission

• AKI-Area Under the Curve (AUC)

  up to day 21 of ICU admission

Study Arms (1)

Critical COVID-19

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

Interventions

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

Critical COVID-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive Critical COVID-19 patients admitted to the ICU

You may qualify if:

• 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

You may not qualify if:

• asymptomatic COVID-19 patients admitted to the ICU for medical reason not related to COVID-19

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Hospital, Antwerp: collaborator
• Ziekenhuis Oost-Limburg: collaborator
• Jessa Hospital: collaborator
• General Hospital Groeninge: collaborator
• AZ Delta: collaborator
• AZ Turnhout: collaborator
• AZ Sint-Jan AV: collaborator

Study Sites (9)

UZ Antwerp

Antwerp, 2650, Belgium

Location

AZ St-Jan AV

Bruges, 8000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Ghent University Hospital

Ghent, 9000, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

AZ Turnhout

Turnhout, 2300, Belgium

Location

Related Publications (7)

• 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.

  PMID: 33060844 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.

  PMID: 32777758 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.

  PMID: 28239173 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.

  PMID: 34252450 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.

  PMID: 32709292 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.

  PMID: 16696865 BACKGROUND

• 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.

  PMID: 35879765 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury; COVID-19

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Eric Hoste, Md, PhD

  University Hospital, Ghent

  STUDY CHAIR

• Greet De Vlieger, Md, PhD

  Universitaire Ziekenhuizen KU Leuven

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: February 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: May 17, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-01

Locations

BE (9)