Stockholm Acute Kidney Injury Cohort

NCT05111535 | Completed

• 1 other identifier: SAKIS
• Study Type: observational
• Target: 1,861
• Locations: 1 country
• Sites: 2

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. 1.Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.
2. 2.One year outcome with focus on renal and cardiovascular outcomes.
3. 3.Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.

Conditions

Acute Kidney Injury

Keywords

acute renal failure; hyperkalemia; major adverse cardiovascular event

Outcome Measures

Primary Outcomes (3)

• In-hospital outcome

  Death

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

• 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

• Long-term outcome

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

  From admission until 10 years

Secondary Outcomes (3)

• In-hospital partial renal recovery

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

• In-hospital renal recovery

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

• In-hospital biomarkers

  From previous values or values at admission until discharge or death, assessed for a period of up to 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Ongoing dialysis treatment.

Sponsors & Collaborators

• Danderyd Hospital: lead

Study Sites (2)

Karolinska Institute at Danderyd University Hospital

Danderyd, Stockholm County, 18288, Sweden

Location

Danderyd University Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury; Hyperkalemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Christina Montgomerie, MD

  Karolinska Institutet and Danderyd University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 8, 2021
• Study Start: January 1, 2009
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

SE (2)