The Stockholm CREAtinine Measurements Project

Hypertension Clinical Trial

— SCREAM  

Official title:

The Stockholm CREAtinine Measurements (SCREAM) Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06239129
• Other study ID #: 000001
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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/

Description:

Please consult cohort description in:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3200000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 0 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiovascular Diseases
• Chronic Kidney Diseases
• Diabetes Mellitus
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Initiation of specific medications
multiple therapies studied within this database

Procedure:
• Undertaking of specific procedures
multiple procedures/surgeries studied within this database

Diagnostic Test:
• Abnormalities in specific laboratory tests
multiple abnormalities in laboratory values (i.e. CRP, cholesterol, eGFR, potassium) studied within this database

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Adverse health events associated to laboratory abnormalities	Same as primary objectives but for other laboratory abnormalities different from kidney function measures	2006-2021