Kidney Failure, ChronicNCT05278702
Autonomic Nervous System Dysfunction in Patients With End-stage Kidney Disease
An observational study of Kidney Failure, Chronic, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- How many people
- 78 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESKD individuals treated with either hemodialysis (standard thrice weekly schedule) or peritoneal dialysis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Department of Nephrology, Hippokration Hospital
Thessaloniki, 54642
Danai Faitatzidou, +302313312930, d.a.n.a.i.90@hotmail.com
About this study
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.
Read the detailed description
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).
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, autonomic nervous system, peritoneal dialysis, end-stage kidney disease, heart rate variability
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis | Not described | |
| peritoneal dialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
Measured: Baseline
Secondary outcomes (29)
The difference in baroreceptor-sensitivity (ms/mmHg) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
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).
Measured: Baseline
The difference in stroke-volume (ml) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
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)
Measured: 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
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).
Measured: Baseline
The difference in total-peripheral-resistance during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
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)
Measured: 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.
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)
Measured: 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.
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)
Measured: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the handgrip test between dialysis session start and session end.
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).
Measured: Baseline
The difference in cardiac output (L/min) during the handgrip test between dialysis session start and session end.
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)
Measured: Baseline
The difference in total peripheral resistance during the handgrip test between dialysis session start and session end.
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)
Measured: Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between dialysis session start and session end.
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)
Measured: Baseline
The difference in stroke volume (ml) during the handgrip test between dialysis session start and session end.
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)
Measured: 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
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)
Measured: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between dialysis session start and session end.
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).
Measured: Baseline
The difference in stroke volume (ml) during the orthostatic test between dialysis session start and session end.
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)
Measured: Baseline
The difference in cardiac output (L/min) during the orthostatic test between dialysis session start and session end.
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)
Measured: Baseline
The difference in the total peripheral resistance during the orthostatic test between dialysis session start and session end.
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)
Measured: Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between dialysis session start and session end.
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)
Measured: 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:.
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)
Measured: Baseline
The difference in the baroreceptor sensitivity (ms/mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
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).
Measured: Baseline
The difference in the stroke volume (ml) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
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)
Measured: Baseline
The difference in the total peripheral resistance during the handgrip test between hemodialysis and peritoneal dialysis patients:.
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)
Measured: Baseline
The difference in the cardiac output (L/min) during the handgrip test between hemodialysis and peritoneal dialysis patients.
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)
Measured: Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients.
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)
Measured: 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.
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)
Measured: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
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).
Measured: Baseline
The difference in cardiac output (L/min) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
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)
Measured: Baseline
The difference in total peripheral resistance during the orthostatic test between hemodialysis and peritoneal dialysis patients.
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)
Measured: Baseline
The difference in stroke volume (ml) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
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)
Measured: Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Apr 2021
- Primary completion20 Mar 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faitatzidou Danai, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278702
- Sponsor's protocol ID
- ΔΔ4844
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11576936Kamal A. Effect of hemodialysis on autonomic dysfunction in patients with chronic renal failure - biomed 2009. Biomed Sci Instrum. 2009;45:280-5.
PubMed 19369776Galiatsatos 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.
PubMed 26272208Heart 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.
PubMed 8598068Parati 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.
PubMed 2500393Dipla 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.
PubMed 27061448Westerhof 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.
PubMed 15201554Faitatzidou D, Dipla K, Theodorakopoulou MP, Koutlas A, Tsitouridis A, Dimitriadis C, Pateinakis P, Zafeiridis A, Papagianni A, Jadoul M, Sarafidis P. Heart rate variability at rest and in response to stress: Comparative study between hemodialysis and peritoneal dialysis patients. Exp Biol Med (Maywood). 2023 Oct;248(20):1745-1753. doi: 10.1177/15353702231198081. Epub 2023 Nov 2.
PubMed 37916412
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Dysfunction in Patients With End-stage Kidney Disease
- ClinicalTrials.gov ID
- NCT05278702
- Acronym / sponsor ID
- ΔΔ4844
- Conditions
- Kidney Failure, Chronic
- Keywords
- hemodialysis, autonomic nervous system, peritoneal dialysis, end-stage kidney disease, heart rate variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis | – | – |
| peritoneal dialysis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESKD individuals treated with either hemodialysis (standard thrice weekly schedule) or peritoneal dialysis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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)
29 secondary outcomes
The difference in baroreceptor-sensitivity (ms/mmHg) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Time frame: Baseline
The difference in stroke-volume (ml) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Time frame: 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
Time frame: Baseline
The difference in total-peripheral-resistance during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the handgrip test between dialysis session start and session end.
Time frame: Baseline
The difference in cardiac output (L/min) during the handgrip test between dialysis session start and session end.
Time frame: Baseline
The difference in total peripheral resistance during the handgrip test between dialysis session start and session end.
Time frame: Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between dialysis session start and session end.
Time frame: Baseline
The difference in stroke volume (ml) during the handgrip test between dialysis session start and session end.
Time frame: 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
Time frame: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between dialysis session start and session end.
Time frame: Baseline
The difference in stroke volume (ml) during the orthostatic test between dialysis session start and session end.
Time frame: Baseline
The difference in cardiac output (L/min) during the orthostatic test between dialysis session start and session end.
Time frame: Baseline
The difference in the total peripheral resistance during the orthostatic test between dialysis session start and session end.
Time frame: Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between dialysis session start and session end.
Time frame: 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:.
Time frame: Baseline
The difference in the baroreceptor sensitivity (ms/mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Time frame: Baseline
The difference in the stroke volume (ml) during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Time frame: Baseline
The difference in the total peripheral resistance during the handgrip test between hemodialysis and peritoneal dialysis patients:.
Time frame: Baseline
The difference in the cardiac output (L/min) during the handgrip test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
The difference in both SBP and DBP (mmHg) during the handgrip test between hemodialysis and peritoneal dialysis patients.
Time frame: 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.
Time frame: Baseline
The difference in baroreceptor sensitivity (ms/mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
The difference in cardiac output (L/min) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
The difference in total peripheral resistance during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
The difference in stroke volume (ml) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
The difference in both SBP and DBP (mmHg) during the orthostatic test between hemodialysis and peritoneal dialysis patients.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Background: PubMed 11576936Savica 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.
- Background: PubMed 19369776Kamal A. Effect of hemodialysis on autonomic dysfunction in patients with chronic renal failure - biomed 2009. Biomed Sci Instrum. 2009;45:280-5.
- Background: PubMed 26272208Galiatsatos 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.
- Background: PubMed 8598068Heart 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.
- Background: PubMed 2500393Parati 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.
- Background: PubMed 27061448Dipla 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.
- Background: PubMed 15201554Westerhof 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.
- Derived from this study: PubMed 37916412Faitatzidou D, Dipla K, Theodorakopoulou MP, Koutlas A, Tsitouridis A, Dimitriadis C, Pateinakis P, Zafeiridis A, Papagianni A, Jadoul M, Sarafidis P. Heart rate variability at rest and in response to stress: Comparative study between hemodialysis and peritoneal dialysis patients. Exp Biol Med (Maywood). 2023 Oct;248(20):1745-1753. doi: 10.1177/15353702231198081. Epub 2023 Nov 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danai Faitatzidou (+302313312930, d.a.n.a.i.90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05278702, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.