Renal Outcome in Patients With COVID-19

Sponsor
University of Giessen (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04353583
Collaborator
(none)
900
1
29.3
30.7

Study Details

Study Description

Brief Summary

Acute kidney injury (AKI) is reported to occur in 0.5-9% of severe acute respiratory distress coronavirus 2-positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of renal outcome of in-hospital patients diagnosed with COVID-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Beginning in December 2019, a novel coronavirus, designated as severe acute respiratory distress coronavirus 2 (SARS-CoV-2), has caused an international outbreak of respiratory illness termed coronavirus disease 2019 (COVID-19). Although the clinical manifestations of COVID-19 are dominated by respiratory symptoms, some patients show severe kidney abnormalities. Acute kidney injury (AKI) is reported to occur in 0.5-9% of SARS-CoV-2 positive patients and AKI has been identified as an independent risk factor for in-hospital mortality. The present study aims to investigate the incidence of of renal outcome of in-hospital patients diagnosed with COVID-19.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Renal Outcome in Patients With Coronavirus Disease 2019 (COVID-19)
    Actual Study Start Date :
    Apr 21, 2020
    Actual Primary Completion Date :
    May 17, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    ICU patients

    Patients with COVID-19 requiring ICU care

    Non-ICU patients

    In-hospital patients with COVID-19 not requiring ICU care

    Outcome Measures

    Primary Outcome Measures

    1. GFR loss [6 months post-hospital admission]

      Serial assessment of serum creatinine and cystatin C

    2. Cystatin C as indicator of mortality [30 days post-hospital admission]

      All-cause mortality

    3. Cystatin C as indicator of respiratory illness [30 days post-hospital admission]

      Ventilator-free days

    4. Cystatin C as indicator of disease severity [30 days post-hospital admission]

      Rate of intensive care unit admission

    Secondary Outcome Measures

    1. Renal function changes during hospital stay [from hospital admission til discharge up to 6 months]

      Serial biomarker assessment

    2. Incidence of AKI [Within 7 days after admission]

      As determined by KDIGO criteria

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with COVID-19 diagnosed by World Health Organisation (WHO) criteria
    Exclusion Criteria:
    • Patients aged less than 18 years

    • Patients with stage-5 chronic kidney disease

    • Patients receiving maintenance dialysis

    • Recipients of solid-organ transplantation

    • Patients with AKI requiring renal replacement therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Giessen and Marburg, Giessen Giessen Hessen Germany 35382

    Sponsors and Collaborators

    • University of Giessen

    Investigators

    • Study Director: Werner Seeger, MD, University Hospital Giessen and Marburg, Giessen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Giessen
    ClinicalTrials.gov Identifier:
    NCT04353583
    Other Study ID Numbers:
    • AZ 58/20
    First Posted:
    Apr 20, 2020
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 19, 2022