- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430438
Effect of Low Versus Standard Dialysate Sodium on 48h Ambulatory BP in Patients With Intradialytic Hypertension
Study Overview
Status
Detailed Description
This is an interventional randomized crossover study performed in the Department of Nephrology, Hippokration Hospital, Thessaloniki, Greece. For the purposes of this study, adult patients (>18 years) with end stage kidney disease (ESKD) being treated with hemodialysis (HD) (on standard thrice-weekly HD treatment) for at least 3 months with intradialytic hypertension, fulfilling the inclusion/exclusion criteria were invited to participate. 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.
Patients will be assessed for eligibility during the selection process (records of peridialytic BP measurements of the previous 2-week period will be assessed). Patients will be instructed to arrive to the Dialysis unit 30 min to 1 hour prior to their scheduled dialysis session, on 3 different dialysis days. Baseline evaluation of participants includes the recording of demographics and anthropometric characteristics, medical history, comorbidities, concomitant medications and dialysis-related parameters, as well as physical examination and venous blood sampling for routine laboratory tests. At baseline evaluation patients' hydration status will be assessed with lung ultrasound, while peridialytic BP and BP over the intradialytic period will be assessed with the Mobil-O-Graph device (IEM, Stolberg, Germany). The study includes two treatment periods (low vs standard dialysate sodium) with washout period of 2 weeks between them. Patients will be randomized to 2 groups, which will receive the intervention in the opposite order. Block randomisation will be used to determine treatment order based on a computer-generated randomization list. The first group (A) will undergo dialysis with low dialysate sodium (137 mEq/L) for 4 sessions starting from a mid-week session (i.e Wednesday or Thursday). Immediately before the beginning of the 4th session patients will be assessed with lung ultrasound and the 48h ambulatory BP monitoring will start using the Mobil-O-Graph device. After a 2-week washout period this group (A) will undergo dialysis with standard dialysate sodium (140 mEq/L) for 4 sessions and at the start of the 4th session, again, patients will be assessed with lung ultrasound and the 48h ABPM will begin. The second group will undergo dialysis first with standard dialysate sodium (140 mEq/L) for 4 sessions and then, after the 2-week washout period, with low dialysate sodium (137 mEq/L) for 4 sessions, with similar evaluations at the end of each intervention. Patients will not be aware of the order in which they will receive the 2 different dialysate sodium concentrations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fotini Iatridi, MD
- Phone Number: +302310892030
- Email: fotini.iatridi@gmail.com
Study Contact Backup
- Name: Pantelis Sarafidis, Prof
- Phone Number: +302310892030
- Email: psarafidis11@yahoo.gr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 <132 or >145 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
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).
|
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
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
|
Experimental: Group B
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).
|
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The difference in 48h ambulatory systolic blood pressure (SBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The difference in 48h ambulatory diastolic blood pressure (DBP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
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
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
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
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
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
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
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
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
|
The difference in ambulatory Augmentation index (AIx) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
|
The difference in ambulatory Augmentation index corrected for heart rate (AIx75) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
|
The difference in ambulatory Augmentation pressure (AP) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
|
The difference in ambulatory arterial stiffness between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
Ambulatory arterial stiffness will be assessed by ambulatory pulse wave velocity (PWV), as recorded with the Mobil-O-Graph device
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
The difference in 48h ambulatory brachial SBP/DBP standard deviation (SD) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
The difference in 48h ambulatory brachial SBP/DBP weighted SD (wSD) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
The difference in 48h ambulatory brachial SBP/DBP coefficient of variation (CV) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
The difference in 48h ambulatory brachial SBP/DBP average real variability (ARV) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
This blood pressure variability (BPV) parameter of SBP/DBP will be calculated based on the ABPM recordings obtained with the Mobil-O-Graph device
|
At the 4th dialysis session and the following interdialytic interval of each intervention (end of weeks 2 and 5)
|
The difference in pre-dialysis body weight between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
|
The difference in interdialytic weight gain (IDWG) between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
|
The difference in hydration status (b-lines) assessed by lung ultrasound between low and standard dialysate sodium in patients with intradialytic hypertension
Time Frame: At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
At the 4th dialysis session of each intervention (end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for intradialytic SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for post-dialysis SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for pre-dialysis body weight.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for IDWG.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference (delta) between baseline and end-of-treatment values of each intervention for hydration status (b-lines).
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for intradialytic SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for pre-dialysis SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for post-dialysis SBP/DBP.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for pre-dialysis body weight.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for IDWG.
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
|
The difference between low and standard dialysate sodium in the delta for hydration status (b-lines).
Time Frame: At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
At baseline and at the 4th dialysis session of each intervention (baseline and end of weeks 2 and 5)
|
Collaborators and Investigators
Investigators
- Study Director: Pantelis Sarafidis, Prof, Aristotle University Of Thessaloniki
Publications and helpful links
General Publications
- 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.
- 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.
- 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 Mar 18. doi: 10.1111/hdi.12921. Online ahead of print.
- 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.
- 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.
- 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
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hypertension
- Kidney Diseases
- Kidney Failure, Chronic
- Pharmaceutical Solutions
- Dialysis Solutions
Other Study ID Numbers
- ΔΔ4954
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Kidney Disease
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
University of MichiganTheravance BiopharmaCompletedEnd-Stage Renal Disease | Stage 5 Chronic Kidney DiseaseUnited States
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedEnd-stage Kidney DiseaseUnited States
-
Ewha Womans UniversityUnknownEnd-Stage Kidney Disease
-
University of ChicagoCompletedEnd-Stage Kidney DiseaseUnited States
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
Sahlgrenska University Hospital, SwedenNot yet recruiting
-
Duke-NUS Graduate Medical SchoolNational University Hospital, Singapore; Singapore General HospitalRecruitingEnd-Stage Kidney DiseaseSingapore
-
University of WashingtonCompleted
-
AbbottTerminatedEnd-Stage Kidney DiseaseUnited States
Clinical Trials on dialysis with low dialysate sodium concentration
-
VA Office of Research and DevelopmentActive, not recruitingEnd-stage Renal DiseaseUnited States
-
University of AarhusCompletedEnd Stage Renal Disease on DialysisDenmark
-
University Hospital, MontpellierRecruitingAcute Kidney Injury | Renal Replacement TherapyFrance
-
University of SydneyPeking University People's Hospital; Institute for Clinical Evaluative Sciences and other collaboratorsRecruitingEnd-Stage Kidney DiseaseAustralia, Canada, United Kingdom, Malaysia, Germany, India
-
UPECLIN HC FM Botucatu UnespCompletedChronic Kidney Diseases Stage 5
-
Brigham and Women's HospitalRecruitingIntradialytic Hypotension | Peri-dialytic Cardiac Rhythms | Electrolyte Changes | pH Changes | Adverse SymptomsUnited States
-
Renal Research InstituteCompleted
-
University of MichiganRenal Research InstituteCompletedChronic Kidney Disease | ArrhythmiaUnited States
-
Yale UniversitySatellite ResearchTerminatedHypertension | Hemodialysis PatientsUnited States
-
Camillians Saint Mary's Hospital LuodongUnknownEnd Stage Renal Disease on DialysisTaiwan