Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension

NCT05430438 | Completed DMC

• 1 other identifier: ΔΔ4954
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 4

Brief Summary

Intradialytic hypertension (IDH) is a well-recognized and established complication of hemodialysis that affects an estimated 10-15% of the dialysis population and is associated with an increased risk for cardiovascular adverse events and mortality. The major pathogenic mechanisms include volume and sodium overload, endothelial dysfunction and enhanced vasoconstriction potentially through the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system (SNS) activation. Preliminary uncontrolled studies have demonstrated that in order to achieve proper control of blood pressure (BP) in patients with IDH, volume control with achievement of dry weight, as well as the minimization of sodium load through alteration of dialysate sodium may improve BP. To this day, 3 studies have attempted to evaluate the effect of low dialysate sodium on BP levels in patients with IDH; one study that included 16 patients, compared the effect of low (5 milliequivalent/litre (mEq/L) lower than serum sodium) versus high (5 mEq/L higher than serum sodium) dialysate sodium concentration on BP levels only during the dialysis session; another study examined the effect of low (136 mEq/L) compared to standard (140 mEq/L) sodium dialysate, again, only on peridialytic and intradialytic BP; and only one randomized cross-over study used 24h ABPM to assess the effect of individualized isonatremic vs hyponatremic vs standard dialysate sodium. Hence, the aim of this study is to examine the effect of low (137mEq/L) vs standard (140mEq/L) dialysate sodium on 48h ambulatory blood pressure monitoring (ABPM) in patients with IDH, using appropriate design of randomized crossover study. In addition this is the first study examining the effect of low dialysate sodium on ambulatory central BP, arterial stiffness indices and BP variability in patients with IDH.

Conditions

Intradialytic Hypertension; End Stage Kidney Disease

Keywords

Intradialytic Hypertension; Dialysis; ESKD; Dialysate sodium

Outcome Measures

Primary Outcomes (1)

• The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)

Secondary Outcomes (28)

• The difference in 48h ambulatory diastolic blood pressure (DBP) between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)

• The difference in intradialytic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session of each intervention (end of weeks 2 and 5)

• The difference in pre-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session of each intervention (end of weeks 2 and 5)

• The difference in post-dialysis SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session of each intervention (end of weeks 2 and 5)

• The difference in ambulatory aortic SBP/DBP between low and standard dialysate sodium in patients with intradialytic hypertension

  At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)

Study Arms (2)

Group A

EXPERIMENTAL

Patients will undergo dialysis (4 sessions) with low dialysate sodium (137 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with standard dialysis sodium (140 mEq/L).

Other: dialysis with low dialysate sodium concentration; Other: dialysis with standard dialysate sodium concentration

Group B

EXPERIMENTAL

Patients will undergo dialysis (4 sessions) with standard dialysate sodium (140 mEq/L) and after a 2-week washout period will undergo dialysis (4 sessions) with low dialysis sodium (137 mEq/L).

Other: dialysis with low dialysate sodium concentration; Other: dialysis with standard dialysate sodium concentration

Interventions

dialysis with low dialysate sodium concentration OTHER

Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 137 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity

Group A; Group B

dialysis with standard dialysate sodium concentration OTHER

Patients will undergo 4 dialysis sessions with a dialysate sodium concentration of 140 mEq/L. The modification of dialysate sodium concentration will be monitored through alteration of sodium conductivity

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Adult ESKD individuals treated with a standard thrice weekly hemodialysis schedule for at least 3 months
• Patients with intradialytic hypertension, defined as SBP rise ≥10 mmHg from pre- to post-dialysis in at least 4 out of 6 consecutive sessions
• Patients that are considered clinically euvolemic
• Ability to provide informed written consent

You may not qualify if:

• Post-dialysis SBP \<130 mmHg in at least 4 out of 6 consecutive sessions during the 2-week selection period, prior to study entry
• Previous non-functional arteriovenous fistula in the contralateral brachial arm area of the one used for vascular access that could interfere with proper ambulatory BP recording
• Patients with contraindications to receive the intervention (low dialysate sodium), i.e patients with frequent intradialytic hypotension episodes requiring intervention with fluid administration
• Pre-dialysis serum sodium \<130 or \>142 mEq/L at recruitment
• Modification of dry weight or antihypertensive treatment during one month before study initiation
• History of seizures or disequilibrium syndrome
• Hospitalization for any cause during one month before study initiation
• History of malignancy or any other condition with poor prognosis

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (4)

Frontis Dialysis Center

Athens, 18757, Greece

Location

Therapeutiki Dialysis Unit

Thessaloniki, 56532, Greece

Location

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

UKC Maribor

Maribor, 2000, Slovenia

Location

Related Publications (9)

• Georgianos PI, Sarafidis PA, Zoccali C. Intradialysis Hypertension in End-Stage Renal Disease Patients: Clinical Epidemiology, Pathogenesis, and Treatment. Hypertension. 2015 Sep;66(3):456-63. doi: 10.1161/HYPERTENSIONAHA.115.05858. Epub 2015 Jul 6. No abstract available.

  PMID: 26150436 BACKGROUND

• Inrig JK, Molina C, D'Silva K, Kim C, Van Buren P, Allen JD, Toto R. Effect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study. Am J Kidney Dis. 2015 Mar;65(3):464-73. doi: 10.1053/j.ajkd.2014.10.021. Epub 2014 Dec 17.

  PMID: 25530107 BACKGROUND

• Nair SV, Balasubramanian K, Ramasamy A, Thamizhselvam H, Gharia S, Periasamy S. Effect of low dialysate sodium in the management of intradialytic hypertension in maintenance hemodialysis patients: A single-center Indian experience. Hemodial Int. 2021 Jul;25(3):399-406. doi: 10.1111/hdi.12921. Epub 2021 Mar 18.

  PMID: 33733579 BACKGROUND

• Bikos A, Angeloudi E, Memmos E, Loutradis C, Karpetas A, Ginikopoulou E, Panagoutsos S, Pasadakis P, Liakopoulos V, Papagianni A, Sarafidis P. A Comparative Study of Short-Term Blood Pressure Variability in Hemodialysis Patients with and without Intradialytic Hypertension. Am J Nephrol. 2018;48(4):295-305. doi: 10.1159/000493989. Epub 2018 Oct 22.

  PMID: 30347395 BACKGROUND

• Agarwal R, Light RP. Intradialytic hypertension is a marker of volume excess. Nephrol Dial Transplant. 2010 Oct;25(10):3355-61. doi: 10.1093/ndt/gfq210. Epub 2010 Apr 16.

  PMID: 20400448 BACKGROUND

• Robberechts T, Allamani M, Galloo X, Wissing KM, Van Der Niepen P. Individualized Isonatremic and Hyponatremic Dialysate Improves Blood Pressure in Patients with Intradialytic Hypertension: A Prospective Cross-Over Study with 24-h Ambulatory Blood Pressure Monitoring. Open Journal of Nephrology 2020; 10:144-157

  BACKGROUND

• Bikos A, Loutradis C, Angeloudi E, Karpetas A, Raptis V, Kalaitzidis R, Panagoutsos S, Pasadakis P, Balaskas I, Liakopoulos V, Papagianni A, Sarafidis PA. The effects of nebivolol and irbesartan on postdialysis and ambulatory blood pressure in patients with intradialytic hypertension: a randomized cross-over study. J Hypertens. 2019 Feb;37(2):432-442. doi: 10.1097/HJH.0000000000001891.

  PMID: 30063644 BACKGROUND

• Marshall MR, Wang MY, Vandal AC, Dunlop JL. Low dialysate sodium levels for chronic haemodialysis. Cochrane Database Syst Rev. 2024 Nov 5;11(11):CD011204. doi: 10.1002/14651858.CD011204.pub3.

  PMID: 39498822 DERIVED

• Iatridi F, Malandris K, Ekart R, Xagas E, Karpetas A, Theodorakopoulou MP, Karagiannidis A, Georgiou A, Papagianni A, Sarafidis P. Low dialysate sodium and 48-h ambulatory blood pressure in patients with intradialytic hypertension: a randomized crossover study. Nephrol Dial Transplant. 2024 Oct 30;39(11):1900-1910. doi: 10.1093/ndt/gfae104.

  PMID: 38710537 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Dialysis

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

Intervention Hierarchy (Ancestors)

Chemistry Techniques, Analytical; Investigative Techniques; Chemical Phenomena

Study Officials

• Pantelis Sarafidis, Prof

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Candidate

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 24, 2022
• Study Start: June 1, 2022
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: October 16, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

GR (3); SL (1)