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Completed

NCT Number: NCT06239129

The Stockholm CREAtinine Measurements Project

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/

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Key information

Conditions

Chronic Kidney Diseases Acute Kidney Injury Cardiovascular Diseases Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hypertension Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

0 year–110 year

Sex eligibility

All sexes

Study type

Observational

About this study

Please consult cohort description in:

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initiation of specific medications

Drug

multiple therapies studied within this database

Other names: multiple therapies studied within this database

Undertaking of specific procedures

Procedure

multiple procedures/surgeries studied within this database

Abnormalities in specific laboratory tests

Diagnostic Test

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

Primary outcomes

  1. Adverse health events by levels of kidney function

    Time frame: 2006-2021

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

  2. Safety and efficacy of medications by levels of kidney function

    Time frame: 2006-2021

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

  3. Effect of medications or conditions on kidney function decline

    Time frame: 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

Secondary outcomes

  1. Adverse health events associated to laboratory abnormalities

    Time frame: 2006-2021

    Same as primary objectives but for other laboratory abnormalities different from kidney function measures

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

The Stockholm CREAtinine Measurements (SCREAM) Project

Acronym: SCREAM

Important dates

Study start
2006
Primary completion
2021
Study completion
2022
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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