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

NCT05278702 | Unknown DMC

• 1 other identifier: ΔΔ4844
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Failure, Chronic

Keywords

hemodialysis; autonomic nervous system; peritoneal dialysis; end-stage kidney disease; heart rate variability

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Baseline

• The difference in stroke-volume (ml) during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.

  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

  Baseline

• The difference in total-peripheral-resistance during mental-arithmetic-test between examination during the session and examination in the out-of-dialysis day.

  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.

  Baseline

Study Arms (2)

hemodialysis

peritoneal dialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Department of Nephrology, Hippokration Hospital

Thessaloniki, 54642, Greece

RECRUITING

Related Publications (8)

• 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.

  PMID: 11576936 BACKGROUND

• Kamal A. Effect of hemodialysis on autonomic dysfunction in patients with chronic renal failure - biomed 2009. Biomed Sci Instrum. 2009;45:280-5.

  PMID: 19369776 BACKGROUND

• 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.

  PMID: 26272208 BACKGROUND

• 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.

  PMID: 8598068 BACKGROUND

• 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.

  PMID: 2500393 BACKGROUND

• 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.

  PMID: 27061448 BACKGROUND

• 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.

  PMID: 15201554 BACKGROUND

• Faitatzidou 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.

  PMID: 37916412 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Danai Faitatzidou

CONTACT

+302313312930; d.a.n.a.i.90@hotmail.com

Pantelis Sarafidis

CONTACT

+302313312930; psarafidis11@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 14, 2022
• Study Start: April 1, 2021
• Primary Completion: March 20, 2022
• Study Completion: December 31, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

GR (1)