Retrospective Study to Describe Prevalence of Hyperkalemi... | NCT03657875

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

NCT03657875

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 6, 2018Actual

Enrollment

53,940Actual

Phase

Not provided

Conditions

Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)

Interventions

Not provided

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2017Actual

Primary Completion Date

Sep 15, 2017Actual

Completion Date

Sep 15, 2017Actual

First Submitted Date

Aug 27, 2018

First Submission Date that Met QC Criteria

Sep 3, 2018

First Posted Date

Sep 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2018

Last Update Posted Date

Sep 6, 2018Actual

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53,940Actual

Outcomes Module

Primary Outcomes

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	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Description

Data collection will be performed from anonymous available database of Independent Laboratory INVITRO.

For the proper calculation of prevalence proportions and proper assessment of associations, the following method of the selection of tests results for corresponding statistical analysis will be applied:

For the analysis of primary endpoint, first available result (chronologically) will always be selected for potassium
For the analysis of all secondary endpoints and associations between potassium levels and levels of sodium (Na), eGFR, urine albumin, HbA1C, and NT-proBNP or BNP, chronologically matching results will be selected for potassium and other corresponding parameter, in this case, first available result (chronologically) will be selected for the parameter of interest (i.e. sodium, creatinine (for eGFR), urine albumin, HbA1C, and NT-proBNP or BNP) and matching result (of the same date or ±1 day) for potassium will be selected
If any first available result is unreliable o