Acute Kidney Injury and Acute Kidney Disease in COVID-19

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04353583
• Other study ID #: AZ 58/20
• Status: Active, not recruiting
• Start date: April 21, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: July 31, 2024
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Corona Virus Infection
• Coronavirus Infections
• Kidney Diseases
• Wounds and Injuries

Locations

Country	Name	City	State
Germany	University Hospital Giessen and Marburg, Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Naicker S, Yang CW, Hwang SJ, Liu BC, Chen JH, Jha V. The Novel Coronavirus 2019 epidemic and kidneys. Kidney Int. 2020 May;97(5):824-828. doi: 10.1016/j.kint.2020.03.001. Epub 2020 Mar 7. No abstract available. — View Citation

Outcome

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