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Autonomic Nervous System Dysfunction in Patients With End-stage Kidney Disease

3 marzo 2022 aggiornato da: Faitatzidou Danai, Aristotle University Of Thessaloniki
The prevalence of autonomic nervous system (ANS) dysfunction in patients with end-stage kidney disease (ESKD) is considered to be increased. The uraemic environment, as well as the high incidence of comorbid conditions affecting the ANS function (e.g. diabetes mellitus, autoimmune and degenerative neurological diseases), have been proposed to cause important alterations in ANS function. The vast majority of evidence on the prevalence of ANS dysfunction in ESKD patients is derived from small studies elaborating simple methodology. Noteworthy, with the exception of a study in 27 hemodialysis patients which assessed ANS function before and after dialysis in relation to left ventricular filling pressures, and a 2005 Dutch study in 21 patients whether or not they had hypotension during dialysis, no other study used advanced methods to analyze heart rate or blood pressure variability from beat-to-beat recordings, such as this study. In addition, there is no study so far investigating possible changes in the ANS function per dialysis session. Finally, to the best of our knowledge, this is the first work evaluating possible differences in ANS function in hemodialysis compared with peritoneal dialysis individuals.

Panoramica dello studio

Stato

Reclutamento

Descrizione dettagliata

This is an observational study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, adult patients (>18 years) with ESKD being treated with hemodialysis (HD) (on standard thrice-weekly HD treatment) or peritoneal dialysis (PD) for at least 3 months, fulfilling the inclusion/exclusion criteria were invited to participate. PD and HD patients will be matched by a blinded member of our team based on age, gender and dialysis vintage (i.e. the duration of time after the point they started renal replacement therapy for ESRD) in a 1:1 ratio. All included patients signed a written informed consent form. The study protocol was approved by the Ethics Committee of the School of Medicine, Aristotle University of Thessaloniki. All procedures and evaluations are performed according to the Declaration of Helsinki 2013 Amendment.

Evaluation of participants includes the recording of demographics and anthropometric characteristics, medical history, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. Participants are instructed to visit the Department one hour before the programmed follow-up visit at their unit (PD patients); HD patients are instructed to visit the Department on 2 consecutive days (mid-week dialysis day and the corresponding dialysis-off day). All procedures are performed in a room with an ambient temperature of 23-24oC. Firstly, participants are oriented and familiarized with the experimental procedures and are prepared for the hemodynamic and cardiovascular examinations. Continuous beat-by-beat BP and heart rate are monitored using finger photoplethysmography (Finometer PRO, Finapres Medical Systems, Amsterdam, the Netherlands) throughout the protocol. An inflatable cuff is placed on the middle finger of the non-access hand maintained at heart level. After a 5-min rest, all participants underwent a mental task (countdown from 100 to 0 by 7, performed twice), an orthostatic test (5 min with the patient at the supine position followed by 5 min with the patient in upright position), and a mild physical task [3-minute submaximal handgrip exercise test (set of 30 s exercise at 35% MVC with 3 s rest] (K-Force, K-invent). At the completion of the exercise protocol, the Rate of Perceived Exertion (RPE) is assessed using the Borg scale.

For data analysis, beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands). From pulse pressure profiles, beat-by-beat heart rate (HR) and stroke volume (SV, ml) will be computed, using the Modelflow method; cardiac output (L/min) and systemic vascular resistance (SVR, mmHg.s/mL), will also be computed using Beatscope. HRV analysis will be performed with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019) by the same researcher to eliminate inter-observer variability. R-R interval series will be checked for ectopic beats or artifacts. The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).

Tipo di studio

Osservativo

Iscrizione (Anticipato)

78

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Thessaloniki, Grecia, 54642
        • Reclutamento
        • Department of Nephrology, Hippokration Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

ESKD individuals treated with either hemodialysis (standard thrice weekly schedule) or peritoneal dialysis

Descrizione

Inclusion Criteria:

  • Age >18 years
  • ESKD individuals treated with either hemodialysis (standard thrice weekly schedule) or peritoneal dialysis for at least 3 months
  • Provision of informed written consent

Exclusion Criteria:

  • Antihypertensive treatment modifcation during one month prior to study enrollment
  • Modification of treatment for neurological disorders one month prior to study enrollment
  • Active malignant disease or other comorbidity with poor prognosis
  • History of neurological disorders (e.g. Parkinson's disease, multiple sclerosis, etc) that cause primary ANS dysfunction
  • History of ANS dysfunction secondary to diabetes mellitus, amyloidosis, autoimmune disorders, etc.
  • Active infection or relevant inter-current illness.
  • History of drug or alcohol abuse or severe mental disorder

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
hemodialysis
peritoneal dialysis

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The difference in the root mean square of successive R-R differences [RMSSD (ms)] parameter of heart rate variability during the mental arithmetic test between the examination during the dialysis session and the examination in the out-of-dialysis day
Lasso di tempo: Baseline
The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. RMSSD will be calculated with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019)
Baseline

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The difference in baroreceptor-sensitivity (ms/mmHg) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Lasso di tempo: Baseline
Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).
Baseline
The difference in stroke-volume (ml) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Lasso di tempo: Baseline
Beat-by-beat stroke volume (ml) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in cardiac-output (L/min) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day
Lasso di tempo: Baseline
Beat-by-beat cardiac output (L/min) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands).
Baseline
The difference in total-peripheral-resistance during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Lasso di tempo: Baseline
Beat-by-beat total peripheral resistance (mmHg.s/mL) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in both SBP and DBP (mmHg) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Lasso di tempo: Baseline
Beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in in the root mean square of successive R-R differences [RMSSD (ms)] parameter of heart rate variability during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. RMSSD will be calculated with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019)
Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).
Baseline
The difference in cardiac output (L/min) during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat cardiac output (L/min) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in total peripheral resistance during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat total peripheral resistance (mmHg.s/mL) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in stroke volume (ml) during the handgrip test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat stroke volume (ml) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in in the root mean square of successive R-R differences [RMSSD (ms)] parameter of heart rate variability during the orthostatic test between dialysis session start and session end
Lasso di tempo: Baseline
The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. RMSSD will be calculated with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019)
Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between dialysis session start and session end.
Lasso di tempo: Baseline
Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).
Baseline
The difference in stroke volume (ml) during the orthostatic test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat stroke volume (ml) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in cardiac output (L/min) during the orthostatic test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat cardiac output (L/min) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in the total peripheral resistance during the orthostatic test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat total peripheral resistance (mmHg.s/mL) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between dialysis session start and session end.
Lasso di tempo: Baseline
Beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in in the root mean square of successive R-R differences [RMSSD (ms)] parameter of heart rate variability during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Lasso di tempo: Baseline
The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. RMSSD will be calculated with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019)
Baseline
The difference in the baroreceptor sensitivity (ms/mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Lasso di tempo: Baseline
Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).
Baseline
The difference in the stroke volume (ml) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Lasso di tempo: Baseline
Beat-by-beat stroke volume (ml) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in the total peripheral resistance during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Lasso di tempo: Baseline
Beat-by-beat total peripheral resistance (mmHg.s/mL) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in the cardiac output (L/min) during the handgrip test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat cardiac output (L/min) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in in the root mean square of successive R-R differences [RMSSD (ms)] parameter of heart rate variability during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
The root mean square of successive differences (RMSSD) between the coupling intervals of adjacent R-R intervals will be used as a parasympathetic activity index. RMSSD will be calculated with the HRV Analysis software Kubios (version 3.3.1, Kubios Oy, 2019)
Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Baroreceptor sensitivity (ms/mmHg) will be assessed by examining the spontaneous fluctuations in the blood pressure as assessed by the cross-correlation method using the Beatscope 1a software).
Baseline
The difference in cardiac output (L/min) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat cardiac output (L/min) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in total peripheral resistance during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat total peripheral resistance (mmHg.s/mL) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in stroke volume (ml) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat stroke volume (ml) will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Lasso di tempo: Baseline
Beat-by-beat SBP and DBP will be averaged per testing session and exported using the Beatscope software (version 1.a, Finapres Medical Systems, Amsterdam, the Netherlands)
Baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 aprile 2021

Completamento primario (Anticipato)

20 marzo 2022

Completamento dello studio (Anticipato)

31 dicembre 2022

Date di iscrizione allo studio

Primo inviato

23 febbraio 2022

Primo inviato che soddisfa i criteri di controllo qualità

3 marzo 2022

Primo Inserito (Effettivo)

14 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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