ClinicalTrials.gg
RecruitingNCT06635590Updated Oct 10, 2024

Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes

An observational study in Chronic Kidney Disease (CKD), Hyperkalemia and Hemodialysis, sponsored by Saglik Bilimleri Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Saglik Bilimleri Universitesi · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Chronic Kidney Disease (CKD)
  • Hyperkalemia
  • Hemodialysis

Keywords

  • echocardiography
  • ECG
  • chronic kidney disease
  • hyperkalemia
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 40 is below the median of 213 across 834 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Saglik Bilimleri Universitesi is the lead sponsor of 453 studies on the registry; 140 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patient with chronic kidney disease presenting to emergency department and having isolated hyperkalemia with or without ECG changes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients over 18 years old
  2. Chronic kidney disease patients with \< 60 mL/min/1.73 m²
  3. Patients with hyperkalemia detected in the emergency department
  4. Patients willing to participate in the study and who sign the consent form

Exclusion criteria

Exclusion Criteria:

  1. Patients under 18 years old
  2. Patients who do not wish to participate in the study
  3. Patients without chronic kidney damage
  4. Patients without detected hyperkalemia
  5. Patients needing cardiopulmonary resuscitation due to hyperkalemia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Target follow-up
30 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. ECHO changes

    Describing echocardiograhic (ECHO) changes of isolated hyperkalemia in patients with chronic kidney disease (CKD)

    Time frame: from enrollment to the end of follow up duration of 30 days

07

Study locations

1 of 1 sites recruiting
  • Etlik City Hospital
    Ankara, 06170, Turkey
    Recruiting
    • Gulsen AKCAY, Associate Professor · Contactgulakcay@yahoo.com.tr · +905052874949
    • Emre CAKAR, Resident · Contactdremrecakar01@gmail.com · +905324940295
    • Gulsen AKCAY, Associate Professor · Principal investigator
    • Emre CAKAR, Resident · Sub investigator
    • Melih GOKCIMEN, specialist · Sub investigator
    • Murat OZDEMIR, specialist · Sub investigator
    • Bedriye Muge SONMEZ, ass.prof · Sub investigator
    • Suleyman KAYISOGLU, Resident · Sub investigator
08

References and documents

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 28314851 ↗
  • Kim MJ, Valerio C, Knobloch GK. Potassium Disorders: Hypokalemia and Hyperkalemia. Am Fam Physician. 2023 Jan;107(1):59-70. PubMed 36689973 ↗
  • Piner 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Feb 2025, 12 months after the start.

Of 274 non-industry observational studies under Renal Insufficiency, Chronic, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 192. This study's planned 12 months is below that.

Counting every sponsor, half of 325 studies reached it within 45 months; a quarter within 22 and three quarters within 191.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2024
First posted
Oct 10, 2024
StartActual
Feb 1, 2024
Primary completionEst.
Feb 1, 2025
CompletionEst.
Feb 1, 2025
Last update
Oct 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06635590
Responsible party
Sponsor
First posted
Oct 10, 2024
Start date
Feb 1, 2024
Primary completion
Feb 1, 2025 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Oct 10, 2024

Study contacts

Gulsen AKCAY, Ass. Prof.
Contact
gulakcay@yahoo.com.tr
+905052874949
Emre CAKAR, Resident
Contact
dremrecakar01@gmail.com
+905324940295
gulsen akcay, ass. prof.
study director · ass. prof. of organization

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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