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

NCT ID: NCT04997915

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-05-17

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.

Conditions

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Critical Illness COVID-19 Pneumonia Acute Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Critical COVID-19

Critical COVID-19 patients admitted to the ICU

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

Intervention Type OTHER

Critical COVID-19 patients admitted to the ICU

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

General Hospital Groeninge

OTHER

Sponsor Role collaborator

AZ Delta

OTHER

Sponsor Role collaborator

AZ Turnhout

OTHER

Sponsor Role collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Hoste, Md, PhD

Role: STUDY_CHAIR

University Hospital, Ghent

Greet De Vlieger, Md, PhD

Role: STUDY_CHAIR

Universitaire Ziekenhuizen KU Leuven

Locations

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UZ Antwerp

Antwerp, , Belgium

Site Status

AZ St-Jan AV

Bruges, , Belgium

Site Status

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Jessa Ziekenhuis

Hasselt, , Belgium

Site Status

AZ Groeninge

Kortrijk, , Belgium

Site Status

UZ Leuven

Leuven, , Belgium

Site Status

AZ Delta

Roeselare, , Belgium

Site Status

AZ Turnhout

Turnhout, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 33060844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32777758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28239173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34252450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32709292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16696865 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35879765 (View on PubMed)

Other Identifiers

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BC-08285

Identifier Type: -

Identifier Source: org_study_id

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