AKI Biomarkers in Coronavirus(COVID)-19

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; COVID; Acute Respiratory Failure

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Marlies Ostermann, MD, PhD; Phone Number: 83036 0044 207 188 3038; Email: Marlies.Ostermann@gstt.nhs.uk
• Study Contact Backup: Name: Nuttha Lumlertgul, MD, PhD; Phone Number: 83036 0044 207 188 3038; Email: Nuttha.Lumlertgul@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's & St Thomas' Hospital
    • Contact: Marlies Ostermann, MD, PhD; Phone Number: 020 71883038; Email: Marlies.Ostermann@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

COVID-19 patients with moderate or severe respiratory disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
COVID-19 patients with acute respiratory disease; Adult patients with COVID-19 and moderate or severe respiratory disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any stage of acute kidney injury	As defined by Kidney Diseases: Improving Global Outcome	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for RRT in first 7 days	Renal replacement therapy requirement at the clinicians' discretion	7 days
Mortality	ICU mortality	7 and 28 days
Duration of mechanical ventilation	Duration	7 and 28 days
Duration of vasopressor support	Duration	7 and 28 days

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University Hospital Muenster
• Investigators: Principal Investigator: Marlies Ostermann, MD, PhD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 27, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Respiratory Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: 283675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No