Chronic Kidney Disease (CKD)NCT06635590
Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes
An observational study of Chronic Kidney Disease (CKD) and Hyperkalemia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Patients with CKD ( eGFR \< \<60 mL/min/1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. Pre and post treatment ECG and echocardiographic findings will be recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (CKD), Hyperkalemia, Hemodialysis
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Feb 2025
- How long will I take part?
- 30 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with chronic kidney disease presenting to emergency department and having isolated hyperkalemia with or without ECG changes
Who may be able to join
- Patients over 18 years old
- Chronic kidney disease patients with eGFR \< 60 mL/min/1.73 m²
- Patients with hyperkalemia detected in the emergency department
- Patients willing to participate in the study and who sign the consent form
Who cannot join
- Patients under 18 years old
- Patients who do not wish to participate in the study
- Patients without chronic kidney damage
- Patients without detected hyperkalemia
- Patients needing cardiopulmonary resuscitation due to hyperkalemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, 06170
Gulsen AKCAY, Associate Professor, +905052874949, gulakcay@yahoo.com.tr
Emre CAKAR, Resident, +905324940295, dremrecakar01@gmail.com
About this study
Official title: The Impact of Hyperkalemia-Induced ECG and ECHO Findings on Early and Late Mortality in Patients With Chronic Kidney Disease
Patients with CKD ( eGFR \< \<60 mL/min/1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. Pre and post treatment ECG and echocardiographic findings will be recorded. Investigator will not intervene with the treatment decision of responsible physician and will not delay any intervetion or treatment for the sake of study.
Data will be compared in terms of ECHO and ECG findings depending on hyperkalemia level and response to treatment.
Read the detailed description
In this study, the ECG and echocardiography (ECHO) findings in patients with chronic kidney failure who present to the Etlik City Hospital Emergency Medicine Department will be recorded and compared with literature. Echocardiography is a rapid, reliable, and non-invasive examination widely used by physicians for the monitoring of critically ill patients in emergency departments and intensive care units worldwide.
For patients with known chronic kidney failure brought to the emergency department, a blood sample (blood gas and/or biochemistry) will be taken for potassium measurement. Subsequently, an ECG, which is a quick and non-invasive test, will be performed, followed by an ECHO, also a quick and non-invasive test, conducted by an experienced physician. The physician performing the ECHO will not be involved in the treatment process. ECG and ECHO findings will be recorded and compared before and after treatment. Patient mortality will be monitored at 24 hours, 7 days, and 30 days, and other causes of mortality will be excluded. The relationship between ECG and ECHO findings and mortality will be statistically investigated.
Based on the premise that hyperkalemia can cause cardiac arrest during diastole, it is hypothesized that there may be right ventricular enlargement in patients with ECG findings indicative of hyperkalemia. In animal studies, echocardiography results during resuscitation have shown right ventricular enlargement in animals with hyperkalemia. Based on this information, we believe that echocardiography findings in hyperkalemic patients may be associated with mortality, and that the combined use of echocardiography and ECG may be effective in predicting mortality
- Conditions
- Chronic Kidney Disease (CKD), Hyperkalemia, Hemodialysis
- Keywords
- echocardiography, ECG, chronic kidney disease, hyperkalemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hyperkalemia | Study is planned as only 1 group of patient with hyperkalemia. Pre and post treatment data obtained from patients via ECG, ECHO and laboratory values will be recorded and evaluated in terms of literature. Patient-based findings will also be recorded and evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECHO changes
Describing echocardiograhic (ECHO) changes of isolated hyperkalemia in patients with chronic kidney disease (CKD)
Measured: from enrollment to the end of follow up duration of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease (CKD)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635590
- Sponsor's protocol ID
- CKD ,HYPERKALEMIA AND ECHO
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weiss JN, Qu Z, Shivkumar K. Electrophysiology of Hypokalemia and Hyperkalemia. Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004667. doi: 10.1161/CIRCEP.116.004667. No abstract available.
PubMed 28314851Kim MJ, Valerio C, Knobloch GK. Potassium Disorders: Hypokalemia and Hyperkalemia. Am Fam Physician. 2023 Jan;107(1):59-70.
PubMed 36689973Piner A, Spangler R. Disorders of Potassium. Emerg Med Clin North Am. 2023 Nov;41(4):711-728. doi: 10.1016/j.emc.2023.07.005.
PubMed 37758419
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Hyperkalemia-Induced ECG and ECHO Findings on Early and Late Mortality in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06635590
- Acronym / sponsor ID
- CKD ,HYPERKALEMIA AND ECHO
- Conditions
- Chronic Kidney Disease (CKD), Hyperkalemia, Hemodialysis
- Keywords
- echocardiography, ECG, chronic kidney disease, hyperkalemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 10 Oct 2024 (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.
Patients with CKD ( eGFR \< \<60 mL/min/1,73 m2) presenting to emergency department with isolated hyperkalemia will be study population. Pre and post treatment ECG and echocardiographic findings will be recorded. Investigator will not intervene with the treatment decision of responsible physician and will not delay any intervetion or treatment for the sake of study.
Data will be compared in terms of ECHO and ECG findings depending on hyperkalemia level and response to treatment.
Detailed description
In this study, the ECG and echocardiography (ECHO) findings in patients with chronic kidney failure who present to the Etlik City Hospital Emergency Medicine Department will be recorded and compared with literature. Echocardiography is a rapid, reliable, and non-invasive examination widely used by physicians for the monitoring of critically ill patients in emergency departments and intensive care units worldwide.
For patients with known chronic kidney failure brought to the emergency department, a blood sample (blood gas and/or biochemistry) will be taken for potassium measurement. Subsequently, an ECG, which is a quick and non-invasive test, will be performed, followed by an ECHO, also a quick and non-invasive test, conducted by an experienced physician. The physician performing the ECHO will not be involved in the treatment process. ECG and ECHO findings will be recorded and compared before and after treatment. Patient mortality will be monitored at 24 hours, 7 days, and 30 days, and other causes of mortality will be excluded. The relationship between ECG and ECHO findings and mortality will be statistically investigated.
Based on the premise that hyperkalemia can cause cardiac arrest during diastole, it is hypothesized that there may be right ventricular enlargement in patients with ECG findings indicative of hyperkalemia. In animal studies, echocardiography results during resuscitation have shown right ventricular enlargement in animals with hyperkalemia. Based on this information, we believe that echocardiography findings in hyperkalemic patients may be associated with mortality, and that the combined use of echocardiography and ECG may be effective in predicting mortality
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperkalemia | – | –Study is planned as only 1 group of patient with hyperkalemia. Pre and post treatment data obtained from patients via ECG, ECHO and laboratory values will be recorded and evaluated in terms of literature. Patient-based findings will also be recorded and evaluated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with chronic kidney disease presenting to emergency department and having isolated hyperkalemia with or without ECG changes
Key inclusion criteria (4 listed)
- Patients over 18 years old
- Chronic kidney disease patients with eGFR \< 60 mL/min/1.73 m²
- Patients with hyperkalemia detected in the emergency department
- Patients willing to participate in the study and who sign the consent form
Key exclusion criteria (5 listed)
- Patients under 18 years old
- Patients who do not wish to participate in the study
- Patients without chronic kidney damage
- Patients without detected hyperkalemia
- Patients needing cardiopulmonary resuscitation due to hyperkalemia
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
ECHO changes
Time frame: from enrollment to the end of follow up duration of 30 days
Describing echocardiograhic (ECHO) changes of isolated hyperkalemia in patients with chronic kidney disease (CKD)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 28314851Weiss JN, Qu Z, Shivkumar K. Electrophysiology of Hypokalemia and Hyperkalemia. Circ Arrhythm Electrophysiol. 2017 Mar;10(3):e004667. doi: 10.1161/CIRCEP.116.004667. No abstract available.
- Results publication: PubMed 36689973Kim MJ, Valerio C, Knobloch GK. Potassium Disorders: Hypokalemia and Hyperkalemia. Am Fam Physician. 2023 Jan;107(1):59-70.
- Results publication: PubMed 37758419Piner A, Spangler R. Disorders of Potassium. Emerg Med Clin North Am. 2023 Nov;41(4):711-728. doi: 10.1016/j.emc.2023.07.005.
- Individual participant dataSharing planned: No
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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.
gulsen akcay, ass. prof. study director
ass. prof. of organization
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 Chronic Kidney Disease (CKD) and Hyperkalemia, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 10 Oct 2024. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gulsen AKCAY, Ass. Prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECHO changes (time frame: from enrollment to the end of follow up duration of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635590, which also lists 3 linked publications.
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 10 Oct 2024.