Acute kIDnEy Injury in coviD-19

Acute Kidney Injury Clinical Trial

— AIDED  

Official title:

Long-term Outcomes After Acute Kidney Injury in Coronavirus Disease (COVID-19)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583293
• Other study ID #: UHDB/2020/076
• Status: Active, not recruiting
• Start date: October 8, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: University Hospitals of Derby and Burton NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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:

1. Details of any medical event and date of medical event since last study follow-up.

2. Details of any hospital re-admission.

3. Details of current medication.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Adult patients greater or equal to 18 years of age.

2. Swab results positive for SARS-CoV-2.

3. Patients admitted to the hospital for =24hrs.

Exclusion Criteria:

1. Paediatric patients as defined by age of <18 years of age.

2. Patients >90 years of age.

3. Swab results negative for SARS-CoV-2.

4. Patients on haemodialysis or peritoneal dialysis, pre-existing CKD stage 5 (eGFR <15ml/min/1.73m2), solid organ transplant.

5. Inability/refusal to give informed consent to participate.

6. Death during the same hospital admission that AKI occurred.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Other:
• No intervention
This study does not involve any intervention or new treatment.

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Derby and Burton NHS Foundation Trust	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of Derby and Burton NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.
Secondary	Incidence of albuminuria at 12-15 months.	Albuminuria will be defined as a urine albumin to creatinine ratio (UACR) of >30mg/mmol.	12-15 months after hospital discharge.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Incidence of hospital readmissions at 6-9 months	Number of hospital readmissions	6-9 months after hospital discharge.
Secondary	Incidence of hospital readmissions at 12-15 months	Number of hospital readmissions	12-15 months after hospital discharge.