title: Low-Sodium Versus Standard-Sodium Peritoneal Dialysis Solution in Hypertensive Patients: A Randomized Controlled Trial.
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/Vurea may be lower. Furthermore, the increased transperitoneal membrane sodium gradient can influence sodium balance with consequences for blood pressure (BP) control.
  
  
  METHODS
  Prospective, randomized, double-blind clinical trial to prove the noninferiority of total weekly Kt/Vurea with low-sodium versus standard-sodium PD solution, with the lower confidence limit above the clinically accepted difference of -0.5.
  
  
  METHODS
  Hypertensive patients (≥ 1 antihypertensive drug, including diuretics, or office systolic BP ≥ 130 mmHg) on continuous ambulatory PD therapy from 17 sites.
  
  
  METHODS
  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.
  
  
  RESULTS
  Primary end point: weekly total Kt/Vurea; secondary outcomes: BP control, safety, and tolerability.
  
  
  METHODS
  Total Kt/Vurea 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 Kt/Vurea could not be confirmed. There was no difference for peritoneal Kt/Vurea (1.70 ± 0.38 with low sodium, 1.77 ± 0.44 with standard sodium), but there was a difference in renal Kt/Vurea (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 < 0.001). BP changed marginally with standard-sodium solution, but decreased with low-sodium PD solution, resulting in less antihypertensive medication.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Nephrology, Medical University of Gdańsk, Gdańsk, Poland.
authors.forename: Bolesław
authors.initials: B
authors.lastname: Rutkowski
authors.affiliation: Scarborough General Hospital, Toronto, Ontario, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Tam
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Maastricht University Medical Center, Maastricht, the Netherlands.
authors.forename: Frank M
authors.initials: FM
authors.lastname: van der Sande
authors.affiliation: Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna, Vienna, Austria.
authors.forename: Andreas
authors.initials: A
authors.lastname: Vychytil
authors.affiliation: Department of Nephrology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Vedat
authors.initials: V
authors.lastname: Schwenger
authors.affiliation: Fresenius Medical Care North America, Waltham, MA.
authors.forename: Rainer
authors.initials: R
authors.lastname: Himmele
authors.affiliation: Fresenius Medical Care, Bad Homburg, Germany. Electronic address: adelheid.gauly@fmc-ag.com.
authors.forename: Adelheid
authors.initials: A
authors.lastname: Gauly
mesh_terms: D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D015312:Hemodialysis Solutions / Q000737:chemistry / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000150:complications*; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009994:Osmolar Concentration; D010531:Peritoneal Dialysis, Continuous Ambulatory / Q000379:methods*; D012964:Sodium / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D000959:Antihypertensive Agents; D015312:Hemodialysis Solutions; D012964:Sodium
keywords: Kt/V; PD solution; Peritoneal dialysis (PD); blood pressure; dialysis adequacy; dialysis dose; double-blind; hypertension control; low-sodium dialysis solution; randomized controlled trial (RCT); renal replacement therapy (RRT); sodium balance; sodium elimination