1. Low-Sodium Versus Standard-Sodium Peritoneal Dialysis Solution in Hypertensive Patients: A Randomized Controlled Trial
- Author
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Andreas Vychytil, Marian Klinger, Władysław Sułowicz, A. Vychytil, Bolesław Rutkowski, Michał Nowicki, Adelheid Gauly, Frank M. van der Sande, Andrzej Książek, P. Tam, Władysław Grzeszczak, B. Rutkowski, C.J.A.M. Konings, F.M. van der Sande, Louis-Jean Vleming, Paul Tam, G. Kopriva, Pieter L. Rensma, Rainer Himmele, V. Schwenger, Vedat Schwenger, D. Ouimet, M. van Buren, Małgorzata Myśliwiec, Interne Geneeskunde, MUMC+: MA Nefrologie (9), RS: FHML non-thematic output, and RS: CARIM - R3.02 - Hypertension and target organ damage
- Subjects
Male ,medicine.medical_treatment ,030232 urology & nephrology ,BLOOD-PRESSURE ,030204 cardiovascular system & hematology ,hypertension control ,Peritoneal dialysis (PD) ,chemistry.chemical_compound ,0302 clinical medicine ,REMOVAL ,Peritoneal Dialysis, Continuous Ambulatory ,Medicine ,Dialysis adequacy ,dialysis adequacy ,SALT ,blood pressure ,sodium balance ,Middle Aged ,Kt/V ,FLUID ,Tolerability ,Nephrology ,Hypertension ,low-sodium dialysis solution ,Female ,double-blind ,Adult ,medicine.medical_specialty ,Sodium ,Urology ,chemistry.chemical_element ,Renal function ,CAPD PATIENTS ,Peritoneal dialysis ,03 medical and health sciences ,randomized controlled trial (RCT) ,Double-Blind Method ,PD solution ,Humans ,KINETICS ,Antihypertensive Agents ,Aged ,business.industry ,MORTALITY ,Osmolar Concentration ,dialysis dose ,TRANSPORT ,Hemodialysis Solutions ,Surgery ,renal replacement therapy (RRT) ,chemistry ,Urea ,Kidney Failure, Chronic ,NA ,business ,Low sodium ,sodium elimination - Abstract
Background: Peritoneal dialysis (PD) solutions with reduced sodium content may have advantages for hypertensive patients; however, they have lower osmolarity and solvent drag, so the achieved Kt/V-urea may be lower. Furthermore, the increased transperitoneal membrane sodium gradient can influence sodium balance with consequences for blood pressure (BP) control.Study Design: Prospective, randomized, double-blind clinical trial to prove the noninferiority of total weekly Kt/V-urea with low-sodium versus standard-sodium PD solution, with the lower confidence limit above the clinically accepted difference of 0.5. Setting & Participants: Hypertensive patients (1 antihypertensive drug, including diuretics, or office systolic BP 130 mm Hg) on continuous ambulatory PD therapy from 17 sites.Intervention: 108 patients were randomly assigned (1:1) to 6-month treatments with either low-sodium (125 mmol/L of sodium; 1.5%, 2.3%, or 4.25% glucose; osmolarity, 338-491 mOsm/L) or standard-sodium (134 mmol/L of sodium; 1.5%, 2.3%, or 4.25% glucose; osmolarity, 356-509 mOsm/L) PD solution.Outcomes: Primary end point: weekly total KtNurea; secondary outcomes: BP control, safety, and tolerability. Measurements: Total KtNurea was determined from 24-hour dialysate and urine collection; BP, by office measurement.Results: Total Kt/Vurea after 12 weeks was 2.53 +/- 0.89 in the low -sodium group (n = 40) and 2.97 +/- 1.58 in the control group (n = 42). The noninferiority of total KtNurea could not be confirmed. There was no difference for peritoneal KtNurea (1.70 +/- 0.38 with low sodium, 1.77 +/- 0.44 with standard sodium), but there was a difference in renal KtNurea (0.83 +/- 0.80 with low sodium, 1.20 +/- 1.54 with standard sodium). Mean daily sodium removal with dialysate at week 12 was 1.188 g higher in the low-sodium group (P Limitations: Broader variability of study population than anticipated, particularly regarding residual kidney function.Conclusions: The noninferiority of the low -sodium PD solution for total Kt/Vurea could not be proved; however, it showed beneficial clinical effects on sodium removal and BP. Am J Kidney Dis. 67(5):753-761. 2016 Fresenius Medical Care. Published by Elsevier Inc. on behalf of the National Kidney Foundation, Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.orgIlicenses/by-nc-nd14.01).
- Published
- 2016
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