Stockholm Acute Kidney Injury Cohort

NCT ID: NCT05111535

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1861 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2018-12-31

Brief Summary

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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

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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).

Conditions

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Acute Kidney Injury

Keywords

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acute renal failure hyperkalemia major adverse cardiovascular event

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonas Spaak

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christina Montgomerie, MD

Role: STUDY_DIRECTOR

Karolinska Institutet and Danderyd University Hospital

Locations

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Karolinska Institute at Danderyd University Hospital

Danderyd, Stockholm County, Sweden

Site Status

Danderyd University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SAKIS

Identifier Type: -

Identifier Source: org_study_id