Acute Kidney Injury and Acute Kidney Disease in COVID-19

November 30, 2023 updated by: University of Giessen

Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients With Coronavirus Disease 2019 (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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Giessen, Hessen, Germany, 35382
        • University Hospital Giessen and Marburg, Giessen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hospitalized patients with diagnosed COVID-19

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
ICU patients
Inpatients with COVID-19 requiring ICU care
Non-ICU patients
Inpatients with COVID-19 not requiring ICU care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cystatin C as indicator of mortality
Time Frame: 30 days post-hospital admission
All-cause mortality
30 days post-hospital admission
Cystatin C as indicator of respiratory illness
Time Frame: 30 days post-hospital admission
Ventilator-free days
30 days post-hospital admission
Cystatin C as indicator of disease severity
Time Frame: 30 days post-hospital admission
Rate of intensive care unit admission
30 days post-hospital admission
Incidence of AKI
Time Frame: 30 days post-hospital admission
Serial assessment of serum creatinine and urine output
30 days post-hospital admission
Cystatin C as indicator of renal disease
Time Frame: 30 days post-hospital admission
AKI and acute kidney disease (AKD)
30 days post-hospital admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function changes during hospital stay
Time Frame: from hospital admission til discharge up to 6 months
Serial biomarker assessment
from hospital admission til discharge up to 6 months
Incidence of AKI
Time Frame: Within 7 days after admission
As determined by KDIGO criteria
Within 7 days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Investigators

  • Study Director: Werner Seeger, MD, University Hospital Giessen and Marburg, Giessen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2020

Primary Completion (Actual)

May 17, 2022

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 17, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZ 58/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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