Table 2.
| a. Daily Trial - Treatment Effects on Outcome Variables | ||||||||
|---|---|---|---|---|---|---|---|---|
| Outcome | Treatment | Observed Data Mean (SD)1. |
6× vs. 3× Treatment Comparison: Mean Changes from Baseline (95% CI)2. |
|||||
| Baseline | F2 | F3–5 | F10–12 | F2 | F3–5 | F10–12 | ||
| Pre-HD SBP [mmHg] | 3× weekly | 146.6 (17.8) | 145.5 (22.3) | 144.8 (17.5) | 147.3 (18.5) | −7.7 (−11.9, −3.5)3 | −6.6 (−10.3,−2.9)3 | −10.0 (−13.9, −6.0)3 |
| 6× weekly | 147.0 (18.9) | 138.7 (20.7) | 137.7 (19.7) | 137.4 (20.5) | ||||
| Pre-HD DBP [mmHg] | 3× weekly | 78.2 (11.6) | 79.4 (13.6) | 78.2 (12.6) | 79.6 (12.0) | −3.9 (−6.5, −1.3)2 | −3.4 (−5.6, −1.2)2 | −5.1 (−7.4, −2.8)3 |
| 6× weekly | 81.5 (11.7) | 76.7 (11.8) | 76.5 (11.7) | 76.0 (11.5) | ||||
| Post-HD SBP [mmHg] | 3× weekly | 134.6 (18.3) | 135.8 (22.7) | 133.6 (19.4) | 134.2 (18.9) | −8.7 (−12.9, −4.6)3 | −8.4 (−12.0, −4.8)3 | −7.9 (−11.8, −3.9)3 |
| 6× weekly | 132.6 (19.0) | 125.7 (17.2) | 124.4 (15.9) | 125.2 (16.0) | ||||
| Post-HD DBP [mmHg] | 3× weekly | 71.9 (11.1) | 73.4 (12.4) | 76.5 (10.4) | 74.1 (12.1) | −3.4 (−5.9, −1.0)2 | −3.1 (−5.2, −1.1)2 | −3.4 (−5.6, −1.2)2 |
| 6× weekly | 72.9 (11.7) | 70.2 (10.0) | 73.9 (13.1) | 72.4 (13.4) | ||||
| Pre-HD Weight [kg] | 3× weekly | 81.8 (20.3) | 82.1 (20.7) | 81.9 (20.5) | 82.0 (20.4) | −1.6 (−2.2, −1.1)3 | −1.3 (−2.0,−0.6)3 | −0.2 (−1.1, 0.7) |
| 6× weekly | 80.2 (21.3) | 78.9 (21.4) | 79.3 (21.5) | 80.3 (21.5) | ||||
| Post-HD Weight [kg] | 3× weekly | 78.9 (19.8) | 79.5 (20.3) | 79.1 (19.9) | 79.2 (19.9) | −0.6 (−1.1, −0.1)1 | −0.36 (−1.07, 0.34) | 0.79 (−0.1, 1.68) |
| 6× weekly | 77.0 (20.8) | 78.0 (20.5) | 77.1 (21.2) | 78.2 (21.2) | ||||
| Interdialytic Weight Gain [kg] | 3× weekly | 3.14 (0.96) | 3.15 (1.11) | 3.11 (1.08) | 3.10 (1.04) | −1.1 (−1.2, −0.9)3 | −0.92 (−1.08, −.76)3 | −1.0 (−1.1, −0.8)3 |
| 6× weekly | 3.16 (0.99) | 2.08 (0.89) | 2.15 (0.77) | 2.11 (0.86) | ||||
| Ultrafiltration Rate (mL/min) | 3× weekly | 14.8 (4.1) | 14.6 (4.6) | 14.6 (4.7) | 14.5 (4.3) | −1.1 (−2.1, −0.1)1 | −0.4 (−1.3, 0.4) | −0.6 (−1.5, 0.3) |
| 6× weekly | 15.0 (5.5) | 13.7 (4.6) | 14.3 (4.1) | 13.9 (4.7) | ||||
| Treatment Time (min / session) | 3× weekly | 214 (27.8) | 213 (29.9) | 215 (31.5) | 217 (30.3) | −64.6 (−69.1, −60.2)3 | −63.2 (−67.9, −58.6)3 | −63.8 (−68.7, −58.9)3 |
| 6× weekly | 219 (27.2) | 150 (24.5) | 153 (26.6) | 154 (29.5) | ||||
| Number of Prescribed Anti-hypertensive Drugs [per patient] | 3× weekly | 2.3 (1.4) | -- | 2.1 (1.4) | 2.0 (1.4) | -- | −0.38 (−0.70 to −0. 08)1 | −0.36 (−0.65 to −0.08)1 |
| 6× weekly | 2.2 (1.6) | -- | 1.6 (1.5) | 1.4 (1.3) | ||||
| b. Nocturnal Trial - Treatment Effects on Outcome Variables | ||||||||
|---|---|---|---|---|---|---|---|---|
| Outcome | Treatment | Observed Data (Mean ± SD)1. |
6× vs. 3× Treatment Comparison: Mean Changes from Baseline (95% CI)2. |
|||||
| Baseline | F2 | F3–5 | F10–12 | F2 | F3–5 | F10–12 | ||
| Pre-HD SBP [mmHg] | 3× weekly | 152.6 (22.2) | 155.7 (23.4) | 155.0 (20.6) | 150.7 (18.6) | −7.3 (−14.2,−0.3)1 | −9.4 (−15.5, −3.2)2 | −8.0 (−14.5, −1.6)1 |
| 6× weekly | 144.9 (13.7) | 141.7 (22.8) | 140.1 (18.9) | 137.0 (20.5) | ||||
| Pre-HD DBP [mmHg] | 3× weekly | 82.9 (13.9) | 84.4 (13.1) | 83.8 (11.8) | 83.0 (12.7) | −4.2 (−8.3, −0.1)1 | −4.9 (−8.5, −1.3)2 | −4.5 (−8.3, −0.7)1 |
| 6× weekly | 79.5 (11.0) | 77.8 (13.6) | 76.7 (11.5) | 76.0 (13.9) | ||||
| Post-HD SBP [mmHg] | 3× weekly | 139.2 (21.2) | 140.8 (22.2) | 140.4 (21.6) | 132.3 (2.8) | −1.2 (−9.0, 6.5) | −6.3 (−13.0, 0.5) | −2.0 (−9.2, 5.2) |
| 6× weekly | 136.1 (18.5) | 137.6 (25.5) | 133.0 (22.6) | 129.3 (20.3) | ||||
| Post-HD DBP [mmHg] | 3× weekly | 76.3 (14.9) | 78.4 (13.3) | 76.5 (10.4) | 74.1 (12.1) | −1.4 (−5.7, 2.9) | −2.4 (−6.1, 1.3) | −1.3 (−5.2, 2.6) |
| 6× weekly | 75.1 (11.9) | 77.0 (14.4) | 73.9 (13.1) | 72.4 (13.4) | ||||
| Pre-HD Weight [kg] | 3× weekly | 85.7 (25.1) | 85.3 (24.9) | 85.7 (25.7) | 86.6 (26.3) | −0.5 (−1.5, 0.5) | −0.4 (−2.0, 1.1) | 0.2 (−2.4, 2.9) |
| 6× weekly | 90.8 (29.0) | 89.0 (29.2) | 89.7 (28.8) | 91.1 (28.9) | ||||
| Post-HD Weight [kg] | 3× weekly | 83.5 (24.1) | 82.9 (24.4) | 83.3 (25.0) | 84.1 (25.6) | 0.1 (−0.9, 1.0) | 0.0 (−1.4, 1.4) | 0.6 (−1.9, 3.1) |
| 6× weekly | 88.6 (28.2) | 88.6 (29.0) | 87.8 (28.6) | 89.1 (28.6) | ||||
| Interdialytic Weight Gain [kg] | 3× weekly | 2.42 (1.24) | 2.36 (1.24) | 2.43 (1.14) | 2.55 (1.02) | −0.6 (−1.0, −0.3)3 | −0.44 (−0.76, −0.17)2 | −0.46 (−0.77, −0.15)2 |
| 6× weekly | 1.72 (0.77) | 1.69 (0.82) | 1.91 (0.65) | 2.04 (0.87) | ||||
| Ultrafiltration Rate (mL/min) | 3× weekly | 10.9 (6.2) | 9.2 (4.1) | 9.6 (4.02) | 10.4 (3.8) | −4.2 (−5.7, −2.7)3 | −3.9 (−5.2, −2.7)3 | −4.1 (−5.4, −2.8)3 |
| 6× weekly | 10.1 (6.4) | 4.7 (2.8) | 5.6 (2.9) | 6.0 (3.63) | ||||
| Treatment Time (min / session) | 3× weekly | 229 (32.9) | 261 (78.2) | 260 (79.7) | 258 (74.8) | 120 (96.4, 143.6)3 | 128 (106, 149)3 | 112 (89, 134)3 |
| 6× weekly | 230 (31.9) | 381 (69.4) | 382 (60.7) | 372 (85.1) | ||||
| Number of Prescribed Anti-hypertensive Drugs [per patient] | 3× weekly | 1.6 (1.1) | -- | 1.6 (1.2) | 1.6 (1.2) | -- | −0.46 (−0.98 to −0.004)1 | −0.44 (−0.89 to −0.03)1 |
| 6× weekly | 1.9 (1.3) | -- | 1.3 (1.6) | 1.1 (1.6) | ||||
1.
For patients with non-missing baseline, 4 month and 12 month values (3× weekly N=92–93, 6× weekly N=103–104)
2.
Results controlling for baseline value and clinical center
1
P < 0.05,
2
P < 0.01,
3
P < 0.001
1.
For patients with non-missing baseline, 4 month and 12 month values (3× weekly N=39, 6× weekly N=41)
2.
Results controlling for baseline value.
1
P < 0.05,
2
P < 0.01,
3
P < 0.001