Acute Kidney InjurySAKISNCT05111535
Stockholm Acute Kidney Injury Cohort
An observational study of Acute Kidney Injury, run by Danderyd Hospital at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 1,861 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 2009to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Ongoing dialysis treatment.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institute at Danderyd University Hospital
Danderyd, Stockholm County, 18288
Danderyd University Hospital
Stockholm, 18288
About this study
Official title: Stockholm Prospective Acute Kidney Injury Cohort Study
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:
- Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.
- One year outcome with focus on renal and cardiovascular outcomes.
- Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes.
Read the 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:
- Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.
- One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).
- Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).
- Conditions
- Acute Kidney Injury
- Keywords
- acute renal failure, hyperkalemia, major adverse cardiovascular event
- Medical subject headings
- Acute Kidney Injury, Hyperkalemia
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital outcome
Death
Measured: 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)
Measured: From admission until 1 year
Long-term outcome
Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)
Measured: From admission until 10 years
Secondary outcomes (3)
In-hospital partial renal recovery
Renal recovery by 30% at the time of discharge or death
Measured: From admission until discharge or death, assessed for a period of up to 3 months
In-hospital renal recovery
Renal recovery by 50% at the time of discharge or death
Measured: From admission until discharge or death, assessed for a period of up to 3 months
In-hospital biomarkers
Changes in biomarkers with focus on potassium, malnutrition, inflammation and acidosis
Measured: From previous values or values at admission until discharge or death, assessed for a period of up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,861 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonas Spaak, Danderyd Hospital
- Investigators
- Christina Montgomerie, MD, Study director, Karolinska Institutet and Danderyd University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111535
- Sponsor's protocol ID
- SAKIS
- Acronym
- SAKIS
- Status last verified
- Oct 2021
- First submitted
- 24 Sep 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared, pending application and approval for the specific research question from the Swedish Ethical Review Authority
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stockholm Prospective Acute Kidney Injury Cohort Study
- ClinicalTrials.gov ID
- NCT05111535
- Acronym / sponsor ID
- SAKIS / SAKIS
- Conditions
- Acute Kidney Injury
- Keywords
- acute renal failure, hyperkalemia, major adverse cardiovascular event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,861 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Descriptive study on patient characteristics, changes in biomarkers and in-hospital outcome.
- One year outcome with focus on renal and cardiovascular outcomes.
- 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:
- Descriptive study on in-hospital outcome (death, renal recovery), patient characteristics, hyperkalemia and changes in biomarkers reflecting inflammation, acidosis and malnutrition.
- One year outcome with focus on renal and cardiovascular outcomes (death, new dialysis, worsened renal function, myocardial infarction, stroke, or heart failure; MARCE).
- Long-term outcome (up to 10 years) with focus on renal and cardiovascular outcomes (MARCE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Ongoing dialysis treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital outcome
Time frame: From admission until discharge or death, assessed for a period of up to 3 months
Death
1-year outcome
Time frame: 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)
Long-term outcome
Time frame: From admission until 10 years
Descriptive study on Major Adverse Renal or Cardiovascular Events (MARCE)
3 secondary outcomes
In-hospital partial renal recovery
Time frame: From admission until discharge or death, assessed for a period of up to 3 months
In-hospital renal recovery
Time frame: From admission until discharge or death, assessed for a period of up to 3 months
In-hospital biomarkers
Time frame: From previous values or values at admission until discharge or death, assessed for a period of up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Undecided. Data may be shared, pending application and approval for the specific research question from the Swedish Ethical Review Authority
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Montgomerie, MD study director
Karolinska Institutet and Danderyd University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Danderyd Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital outcome (time frame: From admission until discharge or death, assessed for a period of up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.