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Not yet recruiting NCT06808152

QTc Interval Changes in Hemodialysis Patients

Observational Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hemodialysis. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Relation Between QTc Interval and Different Dialysate Calcium Concentarions in Hemodialysis Patients in Upper Egypt

Overview

The aim of the study is to assess the correlation of QTc interval and sudden cardiac arrest in hemodialysis patients to the different dialysate calcium concentrations.

Detailed description

Sudden cardiac death (SCD) is the leading cause of death in hemodialysis. On hemodialysis, arrhythmias can occur during and shortly after receiving treatment, independent of traditional cardiovascular risk factors. Calcium, potassium, and magnesium may contribute to the development of arrhythmias during hemodialysis as these cations play a major role in development of the ventricular action potential and propagation of the electrical impulse. The optimal serum calcium range, and type of calcium measurement remains unclear, but KDOQI recommends that the dialysate calcium concentration be decreased as a means to maintain neutral or negative calcium balance and prevent vascular calcification. During hemodialysis, serum-ionized calcium varies directly with the dialysate calcium concentration, so a potential harmful effect of reducing calcium concentrations in the dialysate and serum of hemodialysis patients may lead to an increased risk of cardiac rhythm disturbances and sudden cardiac arrest (SCA). Changes in serum calcium, in turn, strongly affect the length of the QT interval so, such disparity in repolarization can be assessed by measuring the QT dispersion, that is, the variation in QT interval length, on a standard 12-lead electrocardiogram. This procedure has been shown to be a useful and reliable means of identifying patients at risk of ventricular arrhythmias. Accordingly, The present study is designed to evaluate the effect of dialysate calcium concentration on cardiac electrical stability during hemodialysis treatment by measuring the QT interval and QT dispersion before and after hemodialysis sessions, each with a different concentration of dialysate calcium.

Primary outcome measures

  • Q-T interval changes in hemodialysis patient [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

  • patients with End Stage Kidney Disease (ESKD) on regular hemodialysis (HD), for not less than one year with age above 20 years \& less than 60.

Exclusion criteria

  • Patients with multi- systemic diseases as SLE Patient with organ damage as heart failure, ischemic heart disease, decompensated liver disease \& CVS Patients with organ transplantation Malignancy Patients above 60 years \& below 20 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06808152 · QTc changes in HD patients

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗