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Completed

NCT Number: NCT04997915

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

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.

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Key information

Conditions

Critical Illness Acute Kidney Injury COVID-19 COVID-19 Pneumonia Coronaviridae Infections Coronavirus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Renal Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Antwerp, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Acute Kidney Injury (AKI)

    Time frame: up to day 21 of ICU admission

    AKI occurrence and severity stages defined according to KDIGO

  2. Kidney outcome

    Time frame: day 30 after ICU admission

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

  3. Mortality

    Time frame: day 30 after ICU admission

    Mortality of AKI and no AKI patients will be compared

  4. Survival

    Time frame: 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

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

Secondary outcomes

  1. Acute Kidney Injury (AKI) creatinine criteria

    Time frame: up to day 21 of ICU admission

    AKI occurrence and severity stages defined according to KDIGO creatinine criteria

  2. Acute Kidney Injury (AKI) urine output criteria

    Time frame: up to day 21 of ICU admission

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

  3. Acute Kidney Injury (AKI), rapid reversal

    Time frame: up to day 21 of ICU admission

    Occurrence of AKI for 48-h or less

  4. Acute Kidney Disease (AKD)

    Time frame: up to day 21 of ICU admission

    Occurrence and severity staging of AKD according to KDIGO criteria

  5. AKI-Area Under the Curve (AUC)

    Time frame: up to day 21 of ICU admission

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

  6. Mortality AKD

    Time frame: day 30 after ICU admission

    Mortality of patients with AKD and severity stages of AKD will be compared to no AKI and patients with AKI and different AKI stages

  7. Mortality AKI rapid reversal

    Time frame: day 30 after ICU admission

    Mortality of patients with AKI rapid reversal ill be compared to no AKI and patients with AKI and different AKI stages

  8. Mortality AKI stage 2-3

    Time frame: day 30 after ICU admission

    Mortality of patients with AKI stage 2 or greater and patients with no AKI or AKI stage 1 will be compared

  9. Mortality AKI treated with KRT

    Time frame: day 30 after ICU admission

    Mortality of patients with AKI treated with KRT and patients with no AKI or AKI stage 1, 2 or 3 will be compared

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

    Time frame: day 30 after ICU admission

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

  11. Mortality AKI-AUC

    Time frame: day 30 after ICU admission

    Mortality of quartiles of AKI-AUC will be assessed

  12. Kidney outcome AKI KDIGO creatinine or urine output

    Time frame: day 30 after ICU admission

    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

  13. Duration of AKI and AKD

    Time frame: up to day 21 of ICU admission

    Duration of AKI, AKI on creatinine or urine output criteria and AKI stages, Rapid Reversal of AKI, and AKD and stages

  14. Survival AKI-AUC

    Time frame: 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

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

  15. Recovery of AKI and AKD

    Time frame: day 30 after ICU admission

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

  16. Timing of AKI, AKI severity grades and use of KRT

    Time frame: ICU admission up to day 21

    timing of occurrence of AKI in relation to onset of symptoms, hospital admission, ICU admission

  17. KRT modality

    Time frame: ICU admission up to day 21

    initial modality of KRT and anticoagulation used

  18. use of KRT

    Time frame: ICU admission up to day 21

    number of KRT treatment days, and KRT free days

  19. Subgroup analysis: Mechanical Ventilation

    Time frame: ICU admission up to day 21

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

  20. Subgroup analysis: Chronic Kidney Disease (CKD) (estimated glomerular filtration rate (eGFR)<60 mL/min)

    Time frame: ICU admission up to day 21

    outcomes will be assessed in patients with and without CKD as baseline kidney function

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

    Time frame: ICU admission up to day 21

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

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

    Time frame: ICU admission up to day 21

    outcomes will be assessed in obese patients and non-obese

  23. Subgroup analysis: prone ventilation

    Time frame: ICU admission up to day 21

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

  24. Subgroup analysis: extracorporeal membrane oxygenation (ECMO)

    Time frame: ICU admission up to day 21

    outcomes will be assessed in patients treated with ECMO

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

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

Registry information

Official study title

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

Acronym: COVID-AKI-B

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2021
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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