AKI Biomarkers in Coronavirus(COVID)-19
AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedStudy Start
First participant enrolled
August 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 15, 2022
March 1, 2022
2.4 years
May 27, 2020
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Any stage of acute kidney injury
As defined by Kidney Diseases: Improving Global Outcome
7 days
Secondary Outcomes (4)
need for RRT in first 7 days
7 days
Mortality
7 and 28 days
Duration of mechanical ventilation
7 and 28 days
Duration of vasopressor support
7 and 28 days
Study Arms (1)
COVID-19 patients with acute respiratory disease
Adult patients with COVID-19 and moderate or severe respiratory disease
Eligibility Criteria
COVID-19 patients with moderate or severe respiratory disease
You may qualify if:
- Moderate or severe respiratory disease as defined by Berlin criteria
- COVID-19 positive
- Age ≥ 18 years
You may not qualify if:
- pre-existing AKI
- severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \<20ml/min
- end-stage renal failure on regular dialysis
- kidney transplant within the last 12 months
- pregnancy
- breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's & St Thomas' Hospital
London, SE1 7EH, United Kingdom
Biospecimen
The investigators will collect blood and urine samples for biomarker measurement at the following time points: at the time point of study inclusion, 12h, 24h, 36h, 48h, 60h, and 72h after inclusion.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marlies Ostermann, MD, PhD
Guy's and St Thomas' NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2020
First Posted
May 29, 2020
Study Start
August 20, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 15, 2022
Record last verified: 2022-03