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A Randomized Controlled Trial

Bruce F. Culleton, MD, MSc; Michael Walsh, MD; Scott W. Klarenbach, MD, MSc; Garth Mortis, MD; Narine Scott-Douglas, MD, PhD; Robert R. Quinn, MD; Marcello Tonelli, MD, SM; Sarah Donnelly, MD; Matthias G. Friedrich, MD; Andreas Kumar, MD; Houman Mahallati, MD; Brenda R. Hemmelgarn, MD, PhD; Braden J. Manns, MD, MSc

JAMA. 2007;298:1291-1299.

Context  Morbidity and mortality rates in hemodialysis patients remain excessive. Alterations in the delivery of dialysis may lead to improved patient outcomes.

Objective  To compare the effects of frequent nocturnal hemodialysis vs conventional hemodialysis on change in left ventricular mass and health-related quality of life over 6 months.

Design, Setting, and Participants  A 2-group, parallel, randomized controlled trial conducted at 2 Canadian university centers between August 2004 and December 2006. A total of 52 patients undergoing hemodialysis were recruited.

Intervention  Participants were randomly assigned in a 1:1 ratio to receive nocturnal hemodialysis 6 times weekly or conventional hemodialysis 3 times weekly.

Main Outcome Measures  The primary outcome was change in left ventricular mass, as measured by cardiovascular magnetic resonance imaging. The secondary outcomes were patient-reported quality of life, blood pressure, mineral metabolism, and use of medications.

Results  Frequent nocturnal hemodialysis significantly improved the primary outcome (mean left ventricular mass difference between groups, 15.3 g, 95% confidence interval [CI], 1.0 to 29.6 g; P = .04). Frequent nocturnal hemodialysis did not significantly improve quality of life (difference of change in EuroQol 5-D index from baseline, 0.05; 95% CI, –0.07 to 0.17; P = .43). However, frequent nocturnal hemodialysis was associated with clinically and statistically significant improvements in selected kidney-specific domains of quality of life (P = .01 for effects of kidney disease and P = .02 for burden of kidney disease). Frequent nocturnal hemodialysis was also associated with improvements in systolic blood pressure (P = .01 after adjustment) and mineral metabolism, including a reduction in or discontinuation of antihypertensive medications (16/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional hemodialysis group; P < .001) and oral phosphate binders (19/26 patients in the nocturnal hemodialysis group vs 3/25 patients in the conventional dialysis group; P < .001). No benefit in anemia management was seen with nocturnal hemodialysis.

Conclusion  This preliminary study revealed that, compared with conventional hemodialysis (3 times weekly), frequent nocturnal hemodialysis improved left ventricular mass, reduced the need for blood pressure medications, improved some measures of mineral metabolism, and improved selected measures of quality of life.

Trial Registration  isrctn.org Identifier: ISRCTN25858715

Author Affiliations: Department of Medicine, University of Calgary, Calgary, Alberta, Canada (Drs Culleton, Walsh, Mortis, Scott-Douglas, Quinn, Hemmelgarn, and Manns); Alberta Kidney Disease Network, Alberta, Canada (Drs Culleton, Klarenbach, Scott-Douglas, Tonelli, Hemmelgarn, and Manns); Libin Cardiovascular Institute of Alberta, University of Calgary (Drs Culleton, Scott-Douglas, Friedrich, Hemmelgarn, and Manns); Department of Medicine, University of Alberta, Edmonton, Alberta, Canada (Drs Klarenbach and Tonelli); Department of Radiology, University of Calgary (Drs Donnelly and Mahallati); Stephenson Cardiovascular Magnetic Resonance Centre at the Libin Cardiovascular Institute of Alberta, University of Calgary (Drs Friedrich and Kumar); and Department of Community Health Sciences, University of Calgary (Drs Hemmelgarn and Manns). Dr Culleton is now with Baxter Healthcare, Deerfield, Illinois.

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