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AKI Biomarkers in Coronavirus(COVID)-19

AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04408248
Enrollment
30
Registered
2020-05-29
Start date
2020-08-20
Completion date
2022-12-31
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Acute Respiratory Failure, COVID

Brief summary

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

Detailed description

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients requiring admission to an intensive care unit. In critically ill patients with COVID-19, acute respiratory disease and acute kidney injury (AKI) are very common. Patients with AKI have an increased risk of mortality, especially renal replacement therapy (RRT) is required. The latest Intensive Care National Audit & Research Centre (ICNARC) report shows a 77% ICU mortality in patients with COVID-19 who require mechanical ventilation and RRT. COVID-19 associated AKI is still poorly understood. The exact underlying pathophysiology remains unknown. Furthermore, there are no specific strategies to prevent or treat AKI. Management is supportive consisting of fluid and haemodynamic optimization, discontinuation of nephrotoxic drugs and prevention of nephrotoxic exposures. Ideally, AKI needs to be recognized as early as possible for these supportive measures to be effective. Early prediction of AKI may be valuable to optimize management and improve outcomes. In critically ill patients without COVID-19, the two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to predict the development of AKI. Whether these new biomarkers also predict the development of AKI in critically ill patients with COVID-19 is unknown. The aim of this project is to explore whether urinary cell cycle arrest markers and other renal biomarkers have a role in predicting AKI in critically ill patients with COVID-19 and acute respiratory disease. The results will advance the understanding of this disease and serve to develop strategies for individualized management of this high-risk group.

Interventions

None listed

Sponsors

University Hospital Muenster
CollaboratorOTHER
Guy's and St Thomas' NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Moderate or severe respiratory disease as defined by Berlin criteria 2. COVID-19 positive 3. Age ≥ 18 years

Exclusion criteria

1. pre-existing AKI 2. severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \<20ml/min 3. end-stage renal failure on regular dialysis 4. kidney transplant within the last 12 months 5. pregnancy 6. breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Any stage of acute kidney injury7 daysAs defined by Kidney Diseases: Improving Global Outcome

Secondary

MeasureTime frameDescription
need for RRT in first 7 days7 daysRenal replacement therapy requirement at the clinicians' discretion
Mortality7 and 28 daysICU mortality
Duration of mechanical ventilation7 and 28 daysDuration
Duration of vasopressor support7 and 28 daysDuration

Countries

United Kingdom

Contacts

Primary ContactMarlies Ostermann, MD, PhD
Marlies.Ostermann@gstt.nhs.uk0044 207 188 3038
Backup ContactNuttha Lumlertgul, MD, PhD
Nuttha.Lumlertgul@gstt.nhs.uk0044 207 188 3038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026