- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05278702
Autonomic Nervous System Dysfunction in Patients With End-stage Kidney Disease
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Danai Faitatzidou
- Telefonní číslo: +302313312930
- E-mail: d.a.n.a.i.90@hotmail.com
Studijní záloha kontaktů
- Jméno: Pantelis Sarafidis
- Telefonní číslo: +302313312930
- E-mail: psarafidis11@yahoo.gr
Studijní místa
-
-
-
Thessaloniki, Řecko, 54642
- Nábor
- Department of Nephrology, Hippokration Hospital
-
Kontakt:
- Danai Faitatzidou
- Telefonní číslo: +302313312930
- E-mail: d.a.n.a.i.90@hotmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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hemodialysis
|
|
peritoneal dialysis
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The difference in baroreceptor-sensitivity (ms/mmHg) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Časové okno: 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.
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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:.
Časové okno: 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:.
Časové okno: 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:.
Časové okno: 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:.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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.
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.
- Savica V, Musolino R, Di Leo R, Santoro D, Vita G, Bellinghieri G. Autonomic dysfunction in uremia. Am J Kidney Dis. 2001 Oct;38(4 Suppl 1):S118-21. doi: 10.1053/ajkd.2001.27418.
- Kamal A. Effect of hemodialysis on autonomic dysfunction in patients with chronic renal failure - biomed 2009. Biomed Sci Instrum. 2009;45:280-5.
- Galiatsatos P, Parakh K, Monti J, Thavarajah S, Aneke-Ogbu H, Watson A, Kim D, Wang NY, Shafi T, Silber HA. A finger photoplethysmography waveform during the valsalva maneuver detects changes in left heart filling pressure after hemodialysis. BMC Nephrol. 2015 Aug 14;16:138. doi: 10.1186/s12882-015-0135-0.
- Parati G, Casadei R, Groppelli A, Di Rienzo M, Mancia G. Comparison of finger and intra-arterial blood pressure monitoring at rest and during laboratory testing. Hypertension. 1989 Jun;13(6 Pt 1):647-55. doi: 10.1161/01.hyp.13.6.647.
- Dipla K, Kousoula D, Zafeiridis A, Karatrantou K, Nikolaidis MG, Kyparos A, Gerodimos V, Vrabas IS. Exaggerated haemodynamic and neural responses to involuntary contractions induced by whole-body vibration in normotensive obese versus lean women. Exp Physiol. 2016 Jun 1;101(6):717-30. doi: 10.1113/EP085556.
- Westerhof BE, Gisolf J, Stok WJ, Wesseling KH, Karemaker JM. Time-domain cross-correlation baroreflex sensitivity: performance on the EUROBAVAR data set. J Hypertens. 2004 Jul;22(7):1371-80. doi: 10.1097/01.hjh.0000125439.28861.ed.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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