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NCT Number: NCT04353583

Acute Kidney Injury and Acute Kidney Disease in COVID-19

Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.

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Key information

Conditions

Acute Kidney Injury Corona Virus Infection Coronaviridae Infections Coronavirus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nidovirales Infections RNA Virus Infections Renal Insufficiency Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Giessen and Marburg, Giessen

Giessen, Hesse, 35382, Germany

About this study

Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of AKI and renal recovery of inpatients diagnosed with COVID-19.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria

Exclusion criteria

  • Patients aged less than 18 years
  • Patients with stage 4 chronic kidney disease (baseline estimated glomerular filtration rate <30 ml/min/1.73 m2)
  • Patients receiving maintenance dialysis
  • Recipients of solid-organ transplantation

Treatment and study plan

Primary outcomes

  1. Incidence of AKI

    Time frame: 30 days post-hospital admission

    Serial assessment of serum creatinine and urine output

  2. Cystatin C as indicator of mortality

    Time frame: 30 days post-hospital admission

    All-cause mortality

  3. Cystatin C as indicator of renal disease

    Time frame: 30 days post-hospital admission

    AKI and acute kidney disease (AKD)

  4. Cystatin C as indicator of respiratory illness

    Time frame: 30 days post-hospital admission

    Ventilator-free days

  5. Cystatin C as indicator of disease severity

    Time frame: 30 days post-hospital admission

    Rate of intensive care unit admission

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients With Coronavirus Disease 2019 (COVID-19)

Important dates

Study start
2020
Primary completion
2022
Study completion
2025
First posted
Apr 20, 2020
Registry last updated
Mar 6, 2025

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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