Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)NCT03657875
Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network (HEKATE)
An observational study of Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD), run by AstraZeneca at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)
- How many people
- 53,940 participants
- Where
- 1 siteRussia
- Study dates
- 15 Sep 2017to 15 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- 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.
Who cannot join
- Blood test cannot be interpreted due to various reasons.
- Blood samples with sing of hemolysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start15 Sep 2017
- Primary completion15 Sep 2017
- Study completion15 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 53,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657875
- Sponsor's protocol ID
- D1843R00280
- Status last verified
- Sep 2018
- First submitted
- 27 Aug 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Describe Prevalence of Hyperkalemia in Russian Population Based on Large Laboratory Network
- ClinicalTrials.gov ID
- NCT03657875
- Acronym / sponsor ID
- D1843R00280
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53,940 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 15 Sep 2017 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Blood test cannot be interpreted due to various reasons.
- Blood samples with sing of hemolysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia Elevated Plasma K+ Cardiovascular Disease (CVD), run by AstraZeneca at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.