NCT06239129

Brief Summary

The Stockholm CREAtinine Measurements (SCREAM) project is a healthcare utilization cohort including, at present, all adult residents in Stockholm between 2006 and 2021. The region of Stockholm had a population of 2.3 million citizens in 2021and provides universal healthcare with a single unified health-system. Administrative databases with complete information on socidemographic data, healthcare use, diagnoses and therapeutic/surgical procedures, and vital status were enriched with performed laboratory tests, dispensed prescriptions at Swedish pharmacies and validated kidney replacement therapy endpoints. Registries were linked and de-identified by the Swedish National Board of Welfare and are considered to have no or minimal loss to follow-up. Because the study utilized de-identified data, it was deemed not to require informed consent and was approved by the regional ethical review boards and the Swedish National Board of Welfare. For detailed description of available data and linked registers please consult: https://pubmed.ncbi.nlm.nih.gov/35028991/

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
16 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

16 years

First QC Date

January 17, 2024

Last Update Submit

January 26, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Adverse health events by levels of kidney function

    multiple outcomes evaluated such as cardiovascular events, fractures, dementia, cancer, etc, all of them based on claims data and/or laboratory data

    2006-2021

  • Safety and efficacy of medications by levels of kidney function

    multiple outcomes evaluated depending on the treatments of interest, all of them based on claims data and/or laboratory data

    2006-2021

  • Effect of medications or conditions on kidney function decline

    Evaluation of changes in kidney function over time upon occurrence of a certain condition (i.e., heart failure or covid19 infection) or initiation of a specific medication

    2006-2021

Secondary Outcomes (1)

  • Adverse health events associated to laboratory abnormalities

    2006-2021

Interventions

multiple therapies studied within this database

Also known as: multiple therapies studied within this database

multiple procedures/surgeries studied within this database

multiple abnormalities in laboratory values (i.e. CRP, cholesterol, eGFR, potassium) studied within this database

Eligibility Criteria

Age0 Years - 110 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stockholm residents with/without ever testing for creatinine or albumuninuria

You may qualify if:

  • For both cohorts:
  • Be a resident of Stockholm during 2006-2021, of all ages
  • For the primary cohort:
  • To have undertaken at least one test of serum creatinine or albuminuria during 2006-2021. If this condition is met, we will then extract a broad range of laboratory tests
  • For the secondary cohort:
  • Anyone not undertaking a test of serum creatinine or albuminuria will conform the secondary cohort. In this cohort we will not extract any other laboratory test, but will obtain the rest of healthcare information

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Russel WA, Fu EL, Bosi A, Caldinelli A, Inker LA, Chang AR, Levey AS, Carrero JJ. Obesity, Underweight, and Accuracy of eGFR Using Cystatin C and Creatinine in a Northern European Population. J Am Soc Nephrol. 2025 Nov 1;36(11):2177-2189. doi: 10.1681/ASN.0000000760. Epub 2025 Jun 13.

MeSH Terms

Conditions

Renal Insufficiency, ChronicAcute Kidney InjuryDiabetes MellitusCardiovascular DiseasesHypertension

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular Diseases

Study Officials

  • Juan J Carrero, Prof

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiorenal Epidemiology

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 2, 2024

Study Start

January 1, 2006

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

Possibility to share data for collaborative academic research purposes that comply with institutional, national and international ethic principles and legislation on data sharing, access and investigation

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
For the time required to perform the collaborative project
Access Criteria
Primarily by welcoming researchers to analyse the data physically in Stockholm. Exceptionally by opening secure VDI connections to work under our online servers