Clinical trial NCT06635590: Chronic Kidney Disease, Hyperkalemia and Echocardiographic Changes
Official title: The Impact of Hyperkalemia-Induced ECG and ECHO Findings on Early and Late Mortality in Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease (CKD)
Hyperkalemia
Hemodialysis
Keywords: echocardiography
ECG
chronic kidney disease
hyperkalemia
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with chronic kidney disease presenting to emergency department and having isolated hyperkalemia with or without ECG changes

Brief summary: Patients with CKD ( eGFR \&lt; \&lt;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

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old
2. Chronic kidney disease patients with eGFR \&lt; 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:

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

Primary outcomes:
measure: ECHO changes
timeFrame: from enrollment to the end of follow up duration of 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Etlik City Hospital
Study officials:
affiliation: ass. prof. of organization
name: gulsen akcay, ass. prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Kim MJ, Valerio C, Knobloch GK. Potassium Disorders: Hypokalemia and Hyperkalemia. Am Fam Physician. 2023 Jan;107(1):59-70.
citation: 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.