Clinical trial NCT05111535: Stockholm Acute Kidney Injury Cohort
Official title: Stockholm Prospective Acute Kidney Injury Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: acute renal failure
hyperkalemia
major adverse cardiovascular event
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 1861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective observational study, where all patients (aged 18 or above) with AKI admitted to the Department of nephrology at Danderyd University Hospital, Stockholm, Sweden, between 2009 and 2018 were included.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital outcome
timeFrame: From admission until discharge or death, assessed for a period of up to 3 months
measure: 1-year outcome
timeFrame: From admission until 1 year
measure: Long-term outcome
timeFrame: From admission until 10 years
Secondary outcomes:
measure: In-hospital partial renal recovery
timeFrame: From admission until discharge or death, assessed for a period of up to 3 months
measure: In-hospital renal recovery
timeFrame: From admission until discharge or death, assessed for a period of up to 3 months
measure: In-hospital biomarkers
timeFrame: From previous values or values at admission until discharge or death, assessed for a period of up to 3 months
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Karolinska Institute at Danderyd University Hospital
state: Stockholm
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
Study officials:
affiliation: Karolinska Institutet and Danderyd University Hospital
name: Christina Montgomerie, MD
role: STUDY_DIRECTOR
References: