Stockholm Acute Kidney Injury Cohort | NCT05111535

Studies
Stockholm Acute Kidney Injury Cohort

NCT05111535

Sponsor

Danderyd Hospital

Status

Completed

Last Update Posted

Nov 8, 2021Actual

Enrollment

1,861Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Sep 24, 2021

First Submission Date that Met QC Criteria

Oct 27, 2021

First Posted Date

Nov 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2021

Last Update Posted Date

Nov 8, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jonas Spaak, Associate professor, Danderyd HospitalPrincipal Investigator

Lead Sponsor

Danderyd HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,861Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
In-hospital renal recovery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christina Montgomerie, MD	Karolinska Institutet and Danderyd University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska Institute at Danderyd University Hospital		Danderyd	Stockholm County	18288	Sweden
Danderyd University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Data may be shared, pending application and approval for the specific research question from the Swedish Ethical Review Authority

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D006947	Hyperkalemia

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided