Viewing Study NCT05111535


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Study NCT ID: NCT05111535
Status: COMPLETED
Last Update Posted: 2021-11-08
First Post: 2021-09-24
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Stockholm Acute Kidney Injury Cohort
Sponsor: Danderyd Hospital
Organization:

Study Overview

Official Title: Stockholm Prospective Acute Kidney Injury Cohort Study
Status: COMPLETED
Status Verified Date: 2021-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SAKIS
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: