Acute Kidney Injury and Acute Kidney Disease in COVID-19

Completed

• Conditions: Corona Virus Infection; Acute Kidney Injury

• Registration Number: NCT04353583
• Lead Sponsor: University of Giessen

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-17
• Study First Posted: 2020-04-20
• Study Start: 2020-04-21
• Primary Completion: 2022-05-17
• Study Completion: 2025-02-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Giessen and Marburg, Giessen; 🇩🇪 Giessen, Hessen, Germany