Stockholm Acute Kidney Injury Cohort

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT05111535
• Lead Sponsor: Danderyd Hospital

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).

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Study First Submitted: 2021-09-24
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1861

Inclusion Criteria

Not provided

Exclusion Criteria

Ongoing dialysis treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital outcome	From admission until discharge or death, assessed for a period of up to 3 months	Death
Long-term outcome	From admission until 10 years	Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)
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)

Secondary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (2)

Karolinska Institute at Danderyd University Hospital; 🇸🇪 Danderyd, Stockholm, Sweden

Danderyd University Hospital; 🇸🇪 Stockholm, Sweden