University Hospitals of Derby and Burton NHS Foundation Trust
Derby, Derbyshire, DE22 3DT, United Kingdom
NCT Number: NCT04583293
This is a prospective observational parallel group cohort study that will aim to recruit 220 participants who were admitted to the hospital with COVID-19 between 1st March 2020 and 30th June 2020 (Group A - 110 participants who had COVID-19 with AKI; Group B - 110 participants who had COVID-19 without AKI). Data from groups A and B will be compared with AKI and non-AKI groups from an existing study database (ARID study, n=1125) who were recruited before the outbreak of the COVID-19 pandemic (recruitment 2013-2016) and who have all completed at least three years of follow up. Participants who have recovered from COVID-19 will be matched for analysis to participants from the ARID study for AKI status, baseline estimated glomerular filtration rate (eGFR) stage, age (± 5 years) and presence of diabetes. Potential participants will receive a letter of invitation along with a comprehensive participant information sheet (PIS).
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Notify Me18 year–90 year
All sexes
Observational
Derby, Derbyshire, DE22 3DT, United Kingdom
After the participants have read and understand the PIS, and had sufficient time (at least 24 hours) to consider their participation in this study, the investigators will ask them to sign a consent form, which shows their willingness to take part. The investigators will then collect information from their medical records about their hospital admission with COVID-19, including their age, ethnicity, medical conditions, length of hospital stay, tablets or any other treatments they received, as well as details of their stay in the intensive care unit.
For the two groups - COVID AKI and COVID non-AKI, telephone follow-up with a study questionnaire will be performed at recruitment, 6-9 months and 12-15 months after hospital discharge. The study questionnaire will include the following:
In addition, at the same time points, participants will be asked to attend their general practitioner surgery or other clinic to have simple clinical measurements (height, weight and blood pressure), blood and urine tests.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study does not involve any intervention or new treatment.
Time frame: 12 months after hospital discharge.
Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30%
Time frame: 6-9 months after hospital discharge.
Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
Time frame: 12-15 months after hospital discharge.
Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
Time frame: 6-9 months after hospital discharge.
Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).
Time frame: 12-15 months after hospital discharge.
Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol).
Time frame: 6-9 months after hospital discharge.
Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality
Time frame: 12-15 months after hospital discharge.
Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality
Time frame: 6-9 months after hospital discharge.
Number of hospital readmissions
Time frame: 12-15 months after hospital discharge.
Number of hospital readmissions
University Hospitals of Derby and Burton NHS Foundation Trust
Other
Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)
Acronym: AIDED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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