Identification of Patients at Risk of CKD After AKI

Identification of Patients at Risk of Chronic Kidney Disease After Acute Kidney Injury

The investigators will investigate whether new kidney biomarkers can identify patients who are at risk of chronic kidney disease after an episode of moderate / severe acute kidney injury in ICU.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; Acute Kidney Injury

Detailed Description

Acute kidney injury (AKI) is a common complication during critical illness and associated with serious short and long-term complications. Participants with AKI have an increased risk of developing dysfunction of other organs, including multi-organ failure, a longer stay in hospital and a higher risk of dying. Survivors remain at risk of complications, even if kidney function initially recovers. In particular, they are at high risk of developing chronic kidney disease, dialysis-dependent end-stage kidney disease and cardiovascular comorbidities. At present, the tools to identify patients at highest risk of chronic kidney disease (CKD) are very limited.

The investigators will recruit participants who had AKI whilst in ICU and are scheduled to be discharged from hospital. Within 3 days of discharge from hospital, blood and urine kidney biomarkers will be measured to explore whether there is a correlation with renal function 3 months later and to identify those at highest risk of CKD. In addition, quality of life at 3 months will be assessed.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marlies Ostermann, PhD; Phone Number: 83035 02071887188; Email: Marlies.Ostermann@gstt.nhs.uk
• Study Contact Backup: Name: Gill Arbane; Phone Number: 83035 02071887188; Email: Gill.Arbane@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Recruiting
    • Guy's & St Thomas Foundation Hospital
    • Contact: Marlies Ostermann; Phone Number: 83038 02071887188; 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

• Sampling Method: Probability Sample

Study Population

critically ill adult patients in the ICU

Description

Inclusion Criteria:

critically ill adult patients who had AKI stage II or III whilst in ICU and are scheduled to be discharged from hospital

Exclusion Criteria:

1. known pre-existing end-stage kidney disease or advanced CKD (stage 3b or worse)
2. kidney transplant within the last 12 months
3. known primary renal disease
4. discharge from hospital for end-of-life care
5. transfer to another health care institution for ongoing in-patient care
6. not expected to survive for 3 months
7. pregnancy
8. lack of capacity to give consent
9. receiving regular dialysis at hospital discharge
10. CKD stage 3 or worse at hospital discharge

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
AKI patients; Patients who suffered from AKI whilst in ICU and are awaiting discharge from hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum creatinine	estimated glomerular filtration rate (eGFR) <60ml/min	3 months after discharge from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	mortality	90 days
cardiovascular morbidity	new or worsened cardiovascular morbidity	3 months post hospitalisation
questionnaire	health-related quality of life based on questionnaire EQ-5D-5L	3 months post hospitalisation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimated): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: chronic kidney disease; acute kidney injury; kidney biomarkers
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Acute Kidney Injury
• Other Study ID Numbers: IRAS 319992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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