Continuous 7-day Detection of Arrhythmias in Dialysis Population

• Conditions: Dialysis; Complications; Arrythmia
• Interventions: Diagnostic Test: Carnation Ambulatory Monitor (CAM)

• Registration Number: NCT04071054
• Lead Sponsor: Medical University of Vienna

Brief Summary

The Carnation Ambulatory Monitor (CAM) is an innovative diagnostic patch device that allows to differentiate the different kinds of arrhythmias more precisely than any other ECG-monitoring device. It attaches on the sternum and can be carried for a week without any breaks. This allows a continuous rhythm monitoring without any gap for 7 days.

This device will be used in dialysis patients to monitor arrhythmias during changes in volume and/or electrolyte balance due to dialysis, in the phases after dialysis as well as before dialysis in the short or long intervals between dialysis sessions.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study Start: 2019-08-01
• Study First Submitted: 2019-08-24
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18 years.
• Written informed consent

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Exclusion Criteria

• Participation in another study within 4 weeks before study begin
• Pacemaker
• ICD

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patients	Carnation Ambulatory Monitor (CAM)	-

Primary Outcome Measures

Name	Time	Method
Number of dialysis patients with an arrhythmia	ECG monitoring over 7 days (3 intermittent hemodialysis sessions)	Detection of arrhythmias (including distribution of ventricular and atrial arrhythmias) by means of Carnation Ambulatory Monitor (CAM) in hemodialysis patients during an entire week, thus including all different phases: during/after/before dialysis sessions

Trial Locations

Locations (1)

Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna; 🇦🇹 Vienna, Austria