AKI Biomarkers in Coronavirus(COVID)-19

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04408248
• Other study ID #: 283675
• Status: Recruiting
• Start date: August 20, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Marlies Ostermann, MD, PhD
• Phone: 0044 207 188 3038
• Email: Marlies.Ostermann[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Respiratory Failure
• COVID
• Respiratory Insufficiency

Locations

Country	Name	City	State
United Kingdom	Guy's & St Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	University Hospital Muenster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any stage of acute kidney injury	As defined by Kidney Diseases: Improving Global Outcome	7 days
Secondary	need for RRT in first 7 days	Renal replacement therapy requirement at the clinicians' discretion	7 days
Secondary	Mortality	ICU mortality	7 and 28 days
Secondary	Duration of mechanical ventilation	Duration	7 and 28 days
Secondary	Duration of vasopressor support	Duration	7 and 28 days