SAKIS: Stockholm Acute Kidney Injury Cohort

Sponsor
Danderyd Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05111535
Collaborator
(none)
1,861
2
120
930.5
7.8

Study Details

Study Description

Brief Summary

Since 2009, adult patients with acute kindney injury (AKI) at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.

By 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria (as defined by KDIGO AKI guidelines) and will be evaluated regarding the following main research questions:

  1. Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.

  2. One year outcome with focus on renal and cardiovascular outcomes.

  3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acure kidney injury (AKI) remains a complex clinical challenge associated with high risk for short-term and long-term adverse events. Since 2009 patients with AKI at the department of Nephrology, Danderyd University Hospital and Karolinska Institutet, have been included in a prospective cohort. Adult patients with either s-creatinine >130 micromol/L and previously unknown level, or 30% increase from previous known level were included; patients on dialysis were not included. All patients were treated and evaluated according to a detailed clinical memorandum, and data collected prospectively.

    By 2020, 1861 patiens have been included of which 1519 fulfill current AKI criteria and will be evaluated regarding the following main research questions:

    1. Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.

    2. One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).

    3. Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1861 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Stockholm Prospective Acute Kidney Injury Cohort Study
    Actual Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Dec 31, 2018
    Actual Study Completion Date :
    Dec 31, 2018

    Outcome Measures

    Primary Outcome Measures

    1. In-hospital outcome [From admission until discharge or death, assessed for a period of up to 3 months]

      Death

    2. 1-year outcome [From admission until 1 year]

      Descriptive study on Major Adverse Renal or Cardiovascular Events (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE)

    3. Long-term outcome [From admission until 10 years]

      Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)

    Secondary Outcome Measures

    1. In-hospital partial renal recovery [From admission until discharge or death, assessed for a period of up to 3 months]

      Renal recovery by 30% at the time of discharge or death

    2. In-hospital renal recovery [From admission until discharge or death, assessed for a period of up to 3 months]

      Renal recovery by 50% at the time of discharge or death

    3. In-hospital biomarkers [From previous values or values at admission until discharge or death, assessed for a period of up to 3 months]

      Changes in biomarkers with focus on potassium, malnutrition, inflammation and acidosis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria (one of the following):
    • Serum creatinine (sCr) >130 µmol/l (1.47 mg/dl) at admission with previously unknown baseline,

    • Increase in sCr by 30% from previous stable out-patient value.

    Exclusion Criteria:

    Ongoing dialysis treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Karolinska Institute at Danderyd University Hospital Danderyd Stockholm Sweden 18288
    2 Danderyd University Hospital Stockholm Sweden 18288

    Sponsors and Collaborators

    • Danderyd Hospital

    Investigators

    • Study Director: Christina Montgomerie, MD, Karolinska Institutet and Danderyd University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonas Spaak, Associate professor, Danderyd Hospital
    ClinicalTrials.gov Identifier:
    NCT05111535
    Other Study ID Numbers:
    • SAKIS
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    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
    Keywords provided by Jonas Spaak, Associate professor, Danderyd Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2021