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. Author manuscript; available in PMC: 2013 Jan 1.
Published in final edited form as: Kidney Int. 2012 Mar 28;82(1):90–99. doi: 10.1038/ki.2012.75
Variable Trial Trt Observed Data (Mean ± SD)1 Adjusted Means and Treatment Effects2
(± SE or with 95% Confidence Intervals)
Baseline F4 F12 Month 4 Month 12
Change from
Baseline
Treatment
Comparison
(6x vs. 3x)
Change from
Baseline
Treatment
Comparison
(6x vs. 3x)
Serum Albumin (g/dL)3 Daily 3x 3.95 ± 0.44 3.94 ± 0.4 3.96 ± 0.4 −0.02 ± 0.03 0.08
(0.01,0.14)
P=0.016
0.00 ± 0.03 0.03
(−0.04,0.10)
P=0.41
6x 3.96 ± 0.36 4.0 ± 0.37 3.98 ± 0.36 0.06 ± 0.03 0.03 ± 0.03
Noct. 3x 3.93 ± 0.53 4.1 ± 0.45 4.12 ± 0.39 0.17 ± 0.05 0.03
(−0.10,0.16)
P=0.65
0.20 ± 0.05 −0.01
(−0.14,0.12)
P=0.88
6x 3.88 ± 0.49 4.1 ± 0.49 4.08 ± 0.53 0.2 ± 0.05 0.19 ± 0.05
ePCR (g/d)3 Daily 3x 64.67 ± 17.86 65.09 ± 19.09 64.26 ± 20.02 0.03 ± 1.19 2.87
(−0.27,6.01)
P=0.07
−0.35 ± 1.29 0.82
(−2.54,4.19)
P=0.63
65.37 ± 21.23 67.83 ± 22.46 65.13 ± 22.53 2.90 ± 1.15 0.47 ± 1.21
Noct 6x 62.42 ± 21.6 63.28 ± 21.49 69.97 ± 24.23 1.65 ± 3.24 5.76
(−2.42,13.94)
P=0.17
6.3 ± 3.33 5.65
(−2.98,14.27)
P=0.20
62.86 ± 21.15 70.96 ± 22.05 74.55 ± 38.81 7.41 ± 3.24 11.94 ± 3.45
Predialysis Weight (kg)3 Daily 3x 81.75 ± 20.26 81.89 ± 20.5 81.97 ± 20.37 0.25 ± 0.27 −1.29
(−2.03,−0.56)
P=0.001
0.15 ± 0.38 −0.21
(−1.24,0.82)
P=0.69
6x 80.17 ± 21.26 79.25 ± 21.49 80.28 ± 21.51 −1.05 ± 0.26 −0.06 ± 0.36
Noct. 3x 85.83 ± 25.05 85.73 ± 25.71 86.57 ± 26.25 −0.36 ± 0.49 −0.44
(−1.79,0.91)
P=0.52
0.51 ± 0.86 0.17
(−2.2,2.55)
P=0.89
6x 90.83 ± 28.95 89.69 ± 28.77 91.11 ± 28.87 −0.8 ± 0.48 0.68 ± 0.85
Postdialysis Weight (kg)3 Daily 3x 78.9 ± 19.76 79.1 ± 19.9 79.19 ± 19.86 0.37 ± 0.28 −0.45
(−1.2,0.3)
P=0.24
0.23 ± 0.45 0.62
(−0.59,1.83)
P=0.32
6x 77.01 ± 20.84 77.07 ± 21.18 78.15 ± 21.2 −0.08 ± 0.27 0.85 ± 0.43
Noct. 3x 83.45 ± 24.08 83.3 ± 25.03 84.05 ± 25.64 −0.44 ± 0.45 −0.02
(−1.25,1.22)
P=0.98
0.36 ± 0.79 0.51
(−1.66,2.69)
P=0.64
6x 88.55 ± 28.19 87.8 ± 28.56 89.07 ± 28.56 −0.45 ± 0.44 0.88 ± 0.78
Reactance (ohms) Daily 3x 48.2 ± 12.6 47.8 ± 15.1 47.4 ± 15.2 −0.6 ± 1.2 5.7
(2.5, 8.9)
P<0.001
−0.9 ± 1.5 5.2
(1.3, 9.2)
P=0.010
6x 48.9 ± 14.1 54.5 ± 14.3 53.3 ± 15.3 5.1 ± 1.2 +4.3 ± 1.4
Noct. 3x 48.7 ± 13.3 51.4 ± 15.1 53.9 ± 13.9 2.6 ± 2.6 3.4
(−3.4, 10.2)
P=0.32
+4.5 ± 2.5 1.4
(−5.1, 7.9)
P=0.67
6x 47.5 ± 13.8 54.3 ± 16.9 53.9 ± 16.2 6.0 ± 2.6 +5.8 ± 2.5
Resistance (ohms ) Daily 3x 488 ± 99 471 ± 92 466 ± 91 −11.0 ± 5.8 +36.9
(21.8, 52.1)
P<0.001
−11.7 ± 7.4 30.4
(11.1, 49.6)
P=0.002
6x 460 ± 89 494 ± 96 492 ± 93 26.0 ± 5.4 +18.7 ± 7.0
Noct. 3x 470 ± 90 471 ± 98 483 ± 108 3.4 ± 9.3 +30.8
(4.7, 57.0)
P=0.021
+6.2 ± 12.2 17.9
(−16.5, 52.2)
P=0.30
6x 467 ± 111 493 ± 117 481 ± 94 34.3 ± 9.3 +24.1 ± 12.5
Phase Angle (degrees) Daily 3x 5.21 ± 1.21 5.32 ± 1.44 5.34 ± 1.58 0.01 ± 0.13 +0.30
(−0.03, 0.63)
P=0.075
−0.02 ± 0.15 0.28
(−0.11, 0.67)
P=0.16
6x 5.65 ± 1.74 5.91 ± 1.85 5.78 ± 1.96 0.31 ± 0.12 +0.25 ± 0.14
Noct. 3x 5.54 ± 1.48 5.76 ± 1.48 5.98 ± 1.66 0.16 ± 0.24 +0.09
(−0.53, 0.72)
P=0.77
+0.37 ± 0.22 −0.05
(−0.66, 0.56)
P=0.87
6x 5.49 ± 1.51 5.81 ± 1.69 5.79 ± 1.67 0.25 ± 0.24 +0.32 ± 0.23
Vector Length (ohms/m) Daily 3x 291.8 ± 64.2 281.7 ± 59.3 278.1 ± 58.2 −6.9 ± 3.5 +23.4***
(14.1, 32.7)
P<0.001
−7.5 ± 4.6 19.6**
(7.6, 31.6)
P=0.0015
6x 278.0 ± 61.1 298.8 ± 66.8 297.4 ± 65.2 16.5 ± 3.3 +12.1 ± 4.3
Noct. 3x 274.5 ± 57.3 279.9 ± 67.3 289.4 ± 75.1 4.1 ± 5.7 17.5*
(1.4, 33.5)
P=0.033
+6.0 ± 7.5 9.4
(−11.6, 30.5)
P=0.38
6x 460.5 ± 95.4 496.7 ± 117.5 484.2 ± 93.5 35.6 ± 9.7 +25.2 ± 12.7
Total Body Water (L) Daily 3x 43.9 ± 10.2 44.1 ± 9.7 44.9 ± 9.6 0.5 ± 0.3 −1.7
(−2.4, −1.0)
P<0.001
+0.6 ± 0.3 −1.3
(−2.1, −0.4)
P=0.004
6x 44.5 ± 9.7 43.0 ± 9.9 43.1 ± 10.2 −1.2 ± 0.2 −0.7 ± 0.3
Noct. 3x 46.7 ± 11.4 45.9 ± 11.4 44.7 ± 11.3 −0.3 ± 0.4 −1.1
(−2.3, 0.1)
P=0.065
−0.1 ± 0.6 −0.4
(−2.2, 1.3)
P=0.63
6x 47.9 ± 12.2 47.1 ± 12.2 48.1 ± 11.9 −1.4 ± 0.4 −0.5 ± 0.6
Kinetic Volume (L)3 Daily 3x 36.2 ± 8.6 37.2 ± 9.3 37.1 ± 8.5 0.62 ± 0.45 −1.96
(−3.14,−0.78)
P=0.001
0.31 ± 0.48 −1.55
(−2.8,−0.29)
P=0.02
6x 36.8 ± 9.5 35.6 ± 8.5 35.6 ± 9.1 −1.34 ± 0.43 −1.24 ± 0.45
Noct. 3x 38.2 ± 12.1 39.6 ± 13.6 38.7 ± 13.5 1.32 ± 1.44 −2.53
(−6.21,1.14)
P=0.18
0.97 ± 1.47 −0.56
(−4.38,3.26)
P=0.77
6x 37.6 ± 9.3 36.5 ± 11.0 41.2 ± 20.5 −1.22 ± 1.43 0.42 ± 1.51
Extra-cellular Water (L) Daily 3x 22.9 ± 4.7 23.1 ± 4.7 23.4 ± 4.9 0.26 ± 0.23 −1.26
(−1.87, −0.65)
P<0.001
+0.44 ± 0.26 −1.12
(−1.83, −0.41)
P=0.002
6x 22.7 ± 4.4 21.4 ± 4.3 21.6 ± 4.4 −1.00 ± 0.22 −0.68 ± 0.25
Noct. 3x 23.8 ± 5.6 23.2 ± 5.9 22.3 ± 5.4 −0.38 ± 0.48 −0.76
(−2.09, 0.58)
P=0.26
−0.68 ± 0.45 0.02
(−1.23, 1.27)
P=0.98
6x 24.6 ± 6.2 23.7 ± 6.3 24.3 ± 5.9 −1.13 ± 0.48 −0.66 ± 0.46
Intra-cellular Water (L) Daily 3x 21.0 ± 6.5 21.1 ± 6.4 21.6 ± 6.1 0.27 ± 0.20 −0.46
(−0.99, 0.08)
P=0.094
+0.13 ± 0.23 −0.19
(−0.81, 0.44)
P=0.562
6x 21.9 ± 6.9 21.6 ± 7.0 21.5 ± 7.4 −0.19 ± 0.19 −0.05 ± 0.22
Noct. 3x 22.8 ± 7.3 22.8 ± 6.8 22.4 ± 7.5 −0.02 ± 0.33 −0.12
(−1.04, 0.80)
P=0.80
+0.53 ± 0.43 −0.22
(−1.45, 1.01)
P=0.73
6x 23.3 ± 7.6 23.4 ± 7.4 23.8 ± 7.5 −0.14 ± 0.33 +0.31 ± 0.44
Body Cell Mass (kg) Daily 3x 26.6 ± 8.2 26.7 ± 8.0 27.3 ± 7.7 0.34 ± 0.25 −0.58
(−1.26, 0.10)
P=0.094
+0.17 ± 0.30 −0.23
(−1.03, 0.56)
P=0.56
6x 27.7 ± 8.8 27.3 ± 8.8 27.3 ± 9.3 −0.24 ± 0.24 −0.07 ± 0.28
Noct. 3x 28.9 ± 9.2 28.8 ± 8.6 28.4 ± 9.5 −0.02 ± 0.41 −0.15
(−1.31, 1.01)
P=0.80
+0.67 ± 0.55 −0.28
(−1.84, 1.28)
P=0.73
6x 29.5 ± 9.6 29.7 ± 9.4 30.2 ± 9.5 −0.17 ± 0.41 +0.39 ± 0.56
Lean Body Mass (kg) Daily 3x 44.0 ± 10.2 44.2 ± 9.7 45.0 ± 9.6 0.53 ± 0.26 −1.68
(−2.37, −0.99)
P<0.001
+0.58 ± 0.32 −1.26
(−2.12, −0.41)
P=0.004
6x 44.6 ± 9.8 43.1 ± 9.9 43.2 ± 10.3 −1.15 ± 0.24 −0.68 ± 0.30
Noct. 3x 46.3 ± 11.7 46.1 ± 11.5 44.8 ± 11.4 −0.23 ± 0.41 −1.11
(−2.25, 0.04)
P=0.057
−0.04 ± 0.61 −0.45
(−2.18, 1.28)
P=0.61
6x 47.4 ± 12.5 47.2 ± 12.2 48.2 ± 12.0 −1.34 ± 0.41 −0.49 ± 0.63
% Adiposity Daily 3x 37.6 ± 13.7 36.8 ± 13.4 37.3 ± 12.8 −0.23 ± 0.29 +0.40
(−0.38, 1.18)
P=0.31
−0.09 ± 0.41 0.76
(−0.34, 1.85)
P=0.17
6x 36.3 ± 13.8 36.2 ± 13.5 35.5 ± 12.9 0.18 ± 0.27 +0.67 ± 0.38
Noct. 3x 37.9 ± 14.6 37.7 ± 14.5 37.5 ± 15.1 −0.53 ± 0.57 +0.78
(−0.78, 2.35)
P=0.32
−0.17 ± 0.81 1.90
(−0.36, 4.17)
P=0.10
6x 40.9 ± 17.7 42.5 ± 18.1 44.4 ± 18.5 0.25 ± 0.56 +1.73 ± 0.82
1

Means and standard deviations are provided for constant cohorts with nonmissing values at each of the baseline, month 4 and month 12 visits. Sample sizes ranges from 77 to 116 (3x per week) and 89 to 123 (6x per week) in the Daily Trial, and from 35 to 42 (3x per week) and 33 to 44 (6x per week) in the Nocturnal Trial.

2

Adjusted means and treatment effects were estimated under mixed effects models with adjustment for the baseline level of the outcome and clinical center in the Daily Trial, and the baseline level of the outcome in the Nocturnal Trial.

3

Month 4 and Month 12 designate averages over Months 3-5 and Months 10-12, respectively, for outcomes measured a monthly kinetic modeling sessions.