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The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.

ABSTRACT: Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea), a 1.74-fold higher average number of treatments per week, and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm. We did not find a significant effect of nocturnal hemodialysis for either of the two coprimary outcomes (death or left ventricular mass (measured by MRI) with a hazard ratio of 0.68, or of death or RAND Physical Health Composite with a hazard ratio of 0.91). Possible explanations for the left ventricular mass result include limited sample size and patient characteristics. Secondary outcomes included cognitive performance, self-reported depression, laboratory markers of nutrition, mineral metabolism and anemia, blood pressure and rates of hospitalization, and vascular access interventions. Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension, but no significant benefit among the other main secondary outcomes. There was a trend for increased vascular access events in the nocturnal arm. Thus, we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either coprimary outcome.

SUBMITTER: Rocco MV

PROVIDER: S-EPMC3569086 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.

Rocco Michael V MV Lockridge Robert S RS Beck Gerald J GJ Eggers Paul W PW Gassman Jennifer J JJ Greene Tom T Larive Brett B Chan Christopher T CT Chertow Glenn M GM Copland Michael M Hoy Christopher D CD Lindsay Robert M RM Levin Nathan W NW Ornt Daniel B DB Pierratos Andreas A Pipkin Mary F MF Rajagopalan Sanjay S Stokes John B JB Unruh Mark L ML Star Robert A RA Kliger Alan S AS Kliger A A Eggers P P Briggs J J Hostetter T T Narva A A Star R R Augustine B B Mohr P P Beck G G Fu Z Z Gassman J J Greene T T Daugirdas J J Hunsicker L L Larive B B Li M M Mackrell J J Wiggins K K Sherer S S Weiss B B Rajagopalan S S Sanz J J Dellagrottaglie S S Kariisa M M Tran T T West J J Unruh M M Keene R R Schlarb J J Chan C C McGrath-Chong M M Frome R R Higgins H H Ke S S Mandaci O O Owens C C Snell C C Eknoyan G G Appel L L Cheung A A Derse A A Kramer C C Geller N N Grimm R R Henderson L L Prichard S S Roecker E E Rocco M M Miller B B Riley J J Schuessler R R Lockridge R R Pipkin M M Peterson C C Hoy C C Fensterer A A Steigerwald D D Stokes J J Somers D D Hilkin A A Lilli K K Wallace W W Franzwa B B Waterman E E Chan C C McGrath-Chong M M Copland M M Levin A A Sioson L L Cabezon E E Kwan S S Roger D D Lindsay R R Suri R R Champagne J J Bullas R R Garg A A Mazzorato A A Spanner E E Rocco M M Burkart J J Moossavi S S Mauck V V Kaufman T T Pierratos A A Chan W W Regozo K K Kwok S S

Kidney international 20110720 10

Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments. To study this further, we randomized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week, all with single-use high-flux dialyzers. The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea), a 1.74-fold higher average number of treatments per week, and a 2.45-fold ...[more]

PMID: 21775973

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Project description:BackgroundFew data are available regarding the long-term mortality rate for patients receiving nocturnal home hemodialysis.Study designPosttrial observational study.Setting & participantsFrequent Hemodialysis Network (FHN) Nocturnal Trial participants who consented to extended follow-up.InterventionThe FHN Nocturnal Trial randomly assigned 87 individuals to 6-times-weekly home nocturnal hemodialysis or 3-times-weekly hemodialysis for 1 year. Patients were enrolled starting in March 2006 and follow-up was completed by May 2010. After the 1-year trial concluded, FHN Nocturnal participants were free to modify their hemodialysis prescription.Outcomes & measurementsWe obtained dates of death and kidney transplantation through July 2011 using linkage to the US Renal Data System and queries of study centers. We used log-rank tests and Cox regression to relate mortality to the initial randomization assignment.ResultsMedian follow-up for the trial and posttrial observational period was 3.7 years. In the nocturnal arm, there were 2 deaths during the 12-month trial period and an additional 12 deaths during the extended follow-up. In the conventional arm, the numbers of deaths were 1 and 4, respectively. In the nocturnal dialysis group, the overall mortality HR was 3.88 (95% CI, 1.27-11.79; P=0.01). Using as-treated analysis with a 12-month running treatment average, the HR for mortality was 3.06 (95% CI, 1.11-8.43; P=0.03). Six-month running treatment data analysis showed an HR of 1.12 (95% CI, 0.44-3.22; P=0.7).LimitationsThese results should be interpreted cautiously due to a surprisingly low (0.03 deaths/patient-year) mortality rate for individuals randomly assigned to conventional home hemodialysis, low statistical power for the mortality comparison due to the small sample size, and the high rate of hemodialysis prescription changes.ConclusionsPatients randomly assigned to nocturnal hemodialysis had a higher mortality rate than those randomly assigned to conventional dialysis. The implications of this result require further investigation.

Dataset Information

The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.

Publications

The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial.

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