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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID AKI | Participants who were admitted to the hospital with COVID-19 and developed AKI during their hospital stay. |
| |
| COVID non-AKI | Participants who were admitted to the hospital with COVID-19 and did not develop AKI during their hospital stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This study does not involve any intervention or new treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of kidney disease progression at 12 months. | Kidney disease progression will be defined as a decline in estimated glomerular filtration rate (eGFR; ml/min/1.73m2) of ≥30% | 12 months after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of albuminuria at 6-9 months. | Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol. | 6-9 months after hospital discharge. |
| Incidence of albuminuria at 12-15 months. |
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Inclusion Criteria:
Exclusion Criteria:
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People who were admitted to the hospital with COVID-19:
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| Name | Affiliation | Role |
|---|---|---|
| Nitin V Kolhe, Doctor | University Hospitals of Derby and Burton NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Derby and Burton NHS Foundation Trust | Derby | Derbyshire | DE22 3DT | United Kingdom |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.
| 12-15 months after hospital discharge. |
| Incidence of combined kidney disease progression and albuminuria at 6-9 months. | Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol). | 6-9 months after hospital discharge. |
| Incidence of combined kidney disease progression and albuminuria at 12-15 months. | Combined kidney disease progression outcome of ≥30% decline in eGFR (ml/min.1.73m2) and/or albuminuria (UACR>30mg/mmol). | 12-15 months after hospital discharge. |
| Factors associated with all-cause mortality at 6-9 months. | Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality | 6-9 months after hospital discharge. |
| Factors associated with all-cause mortality at 12-15 months. | Multi-variable Cox proportional hazards models will be used to assess the factors associated with all-cause mortality | 12-15 months after hospital discharge. |
| Incidence of hospital readmissions at 6-9 months | Number of hospital readmissions | 6-9 months after hospital discharge. |
| Incidence of hospital readmissions at 12-15 months | Number of hospital readmissions | 12-15 months after hospital discharge. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |