The Stockholm CREAtinine Measurements Project

Completed

• Conditions: Acute Kidney Injury; Chronic Kidney Diseases; Diabetes Mellitus; Cardiovascular Diseases; Hypertension

• Registration Number: NCT06239129
• Lead Sponsor: Karolinska Institutet

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/

Detailed Description

Please consult cohort description in:

https://pubmed.ncbi.nlm.nih.gov/35028991/ https://pubmed.ncbi.nlm.nih.gov/26798472/

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3200000

Inclusion Criteria

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

Exclusion criteria:

None

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse health events by levels of kidney function	2006-2021	multiple outcomes evaluated such as cardiovascular events, fractures, dementia, cancer, etc, all of them based on claims data and/or laboratory data
Effect of medications or conditions on kidney function decline	2006-2021	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
Safety and efficacy of medications by levels of kidney function	2006-2021	multiple outcomes evaluated depending on the treatments of interest, all of them based on claims data and/or laboratory data

Secondary Outcome Measures

Name	Time	Method
Adverse health events associated to laboratory abnormalities	2006-2021	Same as primary objectives but for other laboratory abnormalities different from kidney function measures