Clinical trial NCT04892745: Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Official title: Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis
Keywords: hemodialysis
electrical impedance
subcutaneous impedancemetry
cutaneo-muscular impedancemetry
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering chronic renal failure and undergoing chronic hemodialysis in Ambroise Paré hospital.

Brief summary: The primary objective of this pilot study aims to describe the modifications of subcutaneous impedancemetry induced by dialysis.

As secondary objectives, the study aims to 1) describe the modifications of cutaneo-muscular impedancemetry induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events. 3) describe the relationship between modifications of cutaneo-muscular impedancemetry induced by dialysis and 1) describe the modifications of cutaneo-muscular impedance induced by dialysis. 2) describe the relationship between modifications of subcutaneous impedancemetry induced by dialysis and - technical conditions of dialysis; - volemic parameters of dialysis; - evolution of liquid compartments in organism during dialysis; - volemic events or neuromuscular events.

Detailed description: The study will be realized in dialysis facility of Ambroise Paré hospital, APHP. The duration of enrollment of subjects will be 3 months, each enrolled patient will has 2 or 3 week's follow-up.

Eligibility criteria: Inclusion Criteria:

* Patient ⩾ 18 years;
* Patient undergoing chronic dialysis in hemodialysis facility of Ambroise Paré hospital;
* Patient has been informed and given no-opposition for participating to the study.

Exclusion Criteria:

* Patient with a pacemaker or an implantable cardioverter defibrillator;
* Patient under guardianship or curatorship;
* Foreign patient under french AME scheme.

Primary outcomes:
measure: Electrical parameters of subcutaneous impedancemetry
timeFrame: at the end of study, up to 4 months
Secondary outcomes:
measure: Cutaneo-muscular impedancemetry assessement
timeFrame: at the end of study, up to 4 months
measure: Whole body impedancemetry assessement
timeFrame: at the end of study, up to 4 months
measure: Incidence of volemic or neuromuscular events
timeFrame: at the end of study, up to 4 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Service de Néphrologie, Hôpital Ambroise Paré, APHP
Study officials:
affiliation: Service de Néphrologie, Hôpital Ambroise Paré, APHP
name: Marie ESSIG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: