Variable | Trial | Trt | Observed Data (Mean ± SD)1 | Adjusted Means and Treatment Effects2 (± SE or with 95% Confidence Intervals) |
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---|---|---|---|---|---|---|---|---|---|
Baseline | F4 | F12 | Month 4 | Month 12 | |||||
Change from Baseline |
Treatment Comparison (6x vs. 3x) |
Change from Baseline |
Treatment Comparison (6x vs. 3x) |
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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 |
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.
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.
Month 4 and Month 12 designate averages over Months 3-5 and Months 10-12, respectively, for outcomes measured a monthly kinetic modeling sessions.