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NCT Number: NCT05111535

Stockholm Acute Kidney Injury Cohort

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperkalemia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institute at Danderyd University Hospital, Danderyd, Stockholm County, Sweden

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About this study

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:

  • Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.
  • One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).
  • Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In-hospital outcome

    Time frame: From admission until discharge or death, assessed for a period of up to 3 months

    Death

  2. 1-year outcome

    Time frame: 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

    Time frame: From admission until 10 years

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

Secondary outcomes

  1. In-hospital partial renal recovery

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Official study title

Stockholm Prospective Acute Kidney Injury Cohort Study

Acronym: SAKIS

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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