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Potassium Kinetic During and After Hemodialysis and Potassium Profiling to Prevent Arrhythmias

NCT04563091 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-03-17

No results posted yet for this study

Summary

The primary objective of the study is the development of a mathematical model for predicting potassium kinetics during and after the dialytic session.

The secondary objectives of the study are:

1. the definition of a correlation between the kinetics of intra and extra-cellular concentrations of potassium during and after the dialytic session and the onset of arrhythmias;
2. the use of the mathematical model to modify the blood concentration of potassium by acting on the composition of the dialysis bath in order to minimize the risk of onset of arrhythmias during and after dialysis.

Conditions

  • Hemodialysis Complication
  • Arrhythmias
  • Potassium Imbalance

Interventions

DEVICE

Hemodialysis with online HFR

1. Hemodialytic therapy using 240-minute online HFR on Flexya® hemodialysis machine (Medtronic, Mirandola, Italy). The blood flow from vascular access will be maintained at values \> 250 ml/minute, the flow of dialysis fluid will be 500 ml/minute. Weight loss during dialytic treatment will be prescribed according to the patient's clinical needs. 2. Assess potassium (intra and extra cellular), sodium, bicarbonatemia, calcemia, urea, blood sugar values and ECG every 30 minutes during dialysis and every 60 minutes after dialysis. 3. Body impedance analysis at time 0 at 240 minutes, after 60 minutes after the end of dialysis and after 7 hours after the end of dialysis. 4. Use of the Natrium sensor (Medtronic, Mirandola, Italy) during HFR dialytic treatment.

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2022-01-15
Completion
2025-01-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04563091 on ClinicalTrials.gov