Clinical trial NCT04408248: AKI Biomarkers in Coronavirus(COVID)-19
Official title: AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Acute Respiratory Failure
Acute Kidney Injury
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University Hospital Muenster
First posted: 2020-05-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COVID-19 patients with moderate or severe respiratory disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any stage of acute kidney injury
timeFrame: 7 days
Secondary outcomes:
measure: need for RRT in first 7 days
timeFrame: 7 days
measure: Mortality
timeFrame: 7 and 28 days
measure: Duration of mechanical ventilation
timeFrame: 7 and 28 days
measure: Duration of vasopressor support
timeFrame: 7 and 28 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's & St Thomas' Hospital
Study officials:
affiliation: Guy's and St Thomas' NHS Foundation Trust
name: Marlies Ostermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: