Identification of Patients at Risk of CKD After AKI

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05740709
Collaborator
(none)
100
33.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Patients at Risk of Chronic Kidney Disease After Acute Kidney Injury
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2025
    Anticipated Study Completion Date :
    Jan 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    AKI patients

    Patients who suffered from AKI whilst in ICU and are awaiting discharge from hospital

    Outcome Measures

    Primary Outcome Measures

    1. serum creatinine [3 months after discharge from hospital]

      estimated glomerular filtration rate (eGFR) <60ml/min

    Secondary Outcome Measures

    1. mortality [90 days]

      mortality

    2. cardiovascular morbidity [3 months post hospitalisation]

      new or worsened cardiovascular morbidity

    3. questionnaire [3 months post hospitalisation]

      health-related quality of life based on questionnaire EQ-5D-5L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Guy's and St Thomas' NHS Foundation Trust

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guy's and St Thomas' NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05740709
    Other Study ID Numbers:
    • IRAS 319992
    First Posted:
    Feb 23, 2023
    Last Update Posted:
    Feb 23, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guy's and St Thomas' NHS Foundation Trust
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2023