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Critical IllnessCOVID-AKI-BNCT04997915

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

An observational study of Critical Illness and COVID-19 Pneumonia, run by University Hospital, Ghent at 9 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU
How many people
1,286 participants
Where
9 sitesBelgium
Study dates
1 Feb 2020to 17 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive Critical COVID-19 patients admitted to the ICU

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Belgium9 sites

  • UZ Antwerp

    Antwerp, 2650

  • AZ St-Jan AV

    Bruges, 8000

  • Ziekenhuis Oost-Limburg

    Genk, 3600

  • Ghent University Hospital

    Ghent, 9000

  • Jessa Ziekenhuis

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • UZ Leuven

    Leuven, 3000

  • AZ Delta

    Roeselare, 8800

  • AZ Turnhout

    Turnhout, 2300

Other trials in Belgium

About this study

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

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.

Read the 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.

Being tested
Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU
Keywords
Acute kidney injury, COVID-19, ICU, Epidemiology, Kidney Replacement Therapy, Acute Kidney Disease, Recovery, Mortality, Survival
Medical subject headings
Critical Illness, Acute Kidney Injury, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Critical COVID-19 patients admitted to the ICU

Study groups in NCT04997915
Study groupRoleWhat they receive
Critical COVID-19Critical COVID-19 patients admitted to the ICU
Receives: Other: Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute Kidney Injury (AKI)

    AKI occurrence and severity stages defined according to KDIGO

    Measured: up to day 21 of ICU admission

  2. Kidney outcome

    use of KRT and eGFR in patients without AKI (no AKI), AKI, and AKI stages

    Measured: day 30 after ICU admission

  3. Mortality

    Mortality of AKI and no AKI patients will be compared

    Measured: day 30 after ICU admission

  4. Survival

    Survival of no AKI, AKI and AKI stages, AKD, and rapid reversal up to day 30 or hospital discharge whichever comes last

    Measured: 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)

  1. Acute Kidney Injury (AKI) creatinine criteria

    AKI occurrence and severity stages defined according to KDIGO creatinine criteria

    Measured: up to day 21 of ICU admission

  2. Acute Kidney Injury (AKI) urine output criteria

    AKI occurrence and severity stages defined according to KDIGO urine output criteria

    Measured: up to day 21 of ICU admission

  3. Acute Kidney Injury (AKI), rapid reversal

    Occurrence of AKI for 48-h or less

    Measured: up to day 21 of ICU admission

  4. Acute Kidney Disease (AKD)

    Occurrence and severity staging of AKD according to KDIGO criteria

    Measured: up to day 21 of ICU admission

  5. AKI-Area Under the Curve (AUC)

    Assessment of AKI-AUC which is defined as the sum of the daily maximum severity stage of AKI

    Measured: up to day 21 of ICU admission

  6. 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

    Measured: day 30 after ICU admission

  7. 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

    Measured: day 30 after ICU admission

  8. 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

    Measured: day 30 after ICU admission

  9. 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

    Measured: day 30 after ICU admission

  10. Mortality AKI creatinine criteria versus urine output criteria versus full KDIGO

    Mortality of patients with AKI and patients with no AKI will be compared

    Measured: day 30 after ICU admission

  11. Mortality AKI-AUC

    Mortality of quartiles of AKI-AUC will be assessed

    Measured: day 30 after ICU admission

  12. 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

    Measured: day 30 after ICU admission

  13. 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

    Measured: up to day 21 of ICU admission

  14. Survival AKI-AUC

    Survival up to day 30 or hospital discharge (whichever is last) for quartiles of AKI-AUC will be assessed

    Measured: 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

  15. Recovery of AKI and AKD

    Recovery of AKI, AKI stages, AKD and AKD stages, KRT will be assessed

    Measured: day 30 after ICU admission

  16. 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

    Measured: ICU admission up to day 21

  17. KRT modality

    initial modality of KRT and anticoagulation used

    Measured: ICU admission up to day 21

  18. use of KRT

    number of KRT treatment days, and KRT free days

    Measured: ICU admission up to day 21

  19. Subgroup analysis: Mechanical Ventilation

    outcomes will be assessed in patients with and without mechanical ventilation at time of start of AKI

    Measured: ICU admission up to day 21

  20. 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

    Measured: ICU admission up to day 21

  21. Subgroup analysis: elderly (>= 65 y)

    outcomes will be assessed in patients older and younger than 65y

    Measured: ICU admission up to day 21

  22. Subgroup analysis: obese (BMI>30 kg/m2)

    outcomes will be assessed in obese patients and non-obese

    Measured: ICU admission up to day 21

  23. Subgroup analysis: prone ventilation

    outcomes will be assessed in patients treated with mechanical ventilation and in prone position

    Measured: ICU admission up to day 21

  24. Subgroup analysis: extracorporeal membrane oxygenation (ECMO)

    outcomes will be assessed in patients treated with ECMO

    Measured: ICU admission up to day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2021
  2. Study start1 Feb 2020
  3. Primary completion1 Jun 2021
  4. Study completion17 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,286 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04997915
Sponsor's protocol ID
BC-08285
Acronym
COVID-AKI-B
Status last verified
Jan 2022
First submitted
2 Aug 2021
Last updated
26 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • 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.

    PubMed 33060844

  • 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.

    PubMed 32777758

  • 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.

    PubMed 28239173

  • 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.

    PubMed 34252450

  • 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.

    PubMed 32709292

  • 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.

    PubMed 16696865

  • 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.

    PubMed 35879765

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and COVID-19 Pneumonia, run by University Hospital, Ghent at 9 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Kidney Injury (AKI) (time frame: up to day 21 of ICU admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04997915, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.

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