Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)

September 5, 2018 updated by: AstraZeneca

Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network

This is a cross-sectional retrospective study of laboratory records of patients who take electrolytes blood tests containing the data of the serum potassium level. This study is an observational one, and there is no intervention into routine clinical practice either in terms of therapy, or special examinations.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

53940

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients in Russia 18 years and older whose blood samples were analysed in the independent laboratory INVITRO for serum potassium level (K), from 01.01.2015 till 31.12.2016.

From the main dataset with serum potassium level, subgroups will be selected with available serum sodium (Na), creatinine (for calculation of eGFR with CKD-EPI formula), urine albumin, HbA1C, and NT-proBNP or BNP.

Description

Inclusion Criteria:

  • Males and females tested in the Russian centres of INVITRO laboratory from 01.01.2015 till 31.12.2016;
  • 18 years and older;
  • Available electrolytes blood test containing of the serum potassium level of the unique patient fits for interpretation.

Exclusion Criteria:

  • Blood test cannot be interpreted due to various reasons.
  • Blood samples with sing of hemolysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of the individuals with the serum potassium level higher than 5.0, 5.5, and 6.0 mmol/L
Time Frame: One day
To determine the proportion of the individuals with the serum potassium level higher than 5.0, 5.5, and 6.0 mmol/L based on INVITRO laboratory database during 2015-2016 years.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

September 15, 2017

Study Completion (Actual)

September 15, 2017

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

September 3, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1843R00280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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