Stockholm Acute Kidney Injury Cohort

Acute Kidney Injury Clinical Trial

— SAKIS  

Official title:

Stockholm Prospective Acute Kidney Injury Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05111535
• Other study ID #: SAKIS
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: December 31, 2018

Study information

• Verified date: October 2021
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1861
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Locations

Country	Name	City	State
Sweden	Karolinska Institute at Danderyd University Hospital	Danderyd	Stockholm
Sweden	Danderyd University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital outcome	Death	From admission until discharge or death, assessed for a period of up to 3 months
Primary	1-year outcome	Descriptive study on Major Adverse Renal or Cardiovascular Events (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE)	From admission until 1 year
Primary	Long-term outcome	Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)	From admission until 10 years
Secondary	In-hospital partial renal recovery	Renal recovery by 30% at the time of discharge or death	From admission until discharge or death, assessed for a period of up to 3 months
Secondary	In-hospital renal recovery	Renal recovery by 50% at the time of discharge or death	From admission until discharge or death, assessed for a period of up to 3 months
Secondary	In-hospital biomarkers	Changes in biomarkers with focus on potassium, malnutrition, inflammation and acidosis	From previous values or values at admission until discharge or death, assessed for a period of up to 3 months