Background
Methods
Study design, setting and participants
Matching
Outcomes
Measurements
Subset analyses
Statistical methods
Results
Study population
Intention-To-Treat Cohort | Aligned (163 patients) | Not-Aligned (163 patients) | P (aligned vs. not aligned) |
---|---|---|---|
Age [years] | 66.41+/−15.29 | 65.32+/−13.37 | 0.49 |
Hemodialysis vintage [years]* | 2.8 [1.1 to 5.1] | 1.6 [0.4 to 4.4] | < 0.001 |
Male gender [yes/no] | 52.15% | 54.6% | 0.74 |
Catheter [yes/no] | 22.09% | 25.15% | 0.6 |
White Race [yes/no] | 60.74% | 60.12% | 1 |
Diabetes [yes/no] | 65.64% | 66.26% | 1 |
Hispanic Ethnicity [yes/no] | 8.59% | 7.98% | 1 |
Interdialytic weight gain (% of post-dialysis body weight) | 2.53+/−0.93 | 2.67+/−0.97 | 0.19 |
Pre-dialysis systolic blood pressure [mmHg] | 145.17+/−20.05 | 145.12+/−19.33 | 0.98 |
Serum sodium [mEq/L] | 135.8+/−1.35 | 135.76+/−2.47 | 0.86 |
Patients with at least 1 hospitalization [yes/no] | 14.11% | 20.25% | 0.19 |
As-Treated Cohort | Aligned (137 patients) | Not-Aligned (137 patients) | P (aligned vs. not aligned) |
---|---|---|---|
Age [years] | 68.41+/−14.53 | 66.59+/−14.74 | 0.31 |
Hemodialysis vintage [years]* | 3.2 [1.4 to 5.6] | 3.0 [1.2 to 6.6] | 0.66 |
Male gender [yes/no] | 51.82% | 54.01% | 0.81 |
Catheter [yes/no] | 19.71% | 16.79% | 0.64 |
White Race [yes/no] | 60.58% | 56.93% | 0.62 |
Diabetes [yes/no] | 63.5% | 64.96% | 0.9 |
Hispanic Ethnicity [yes/no] | 6.57% | 3.65% | 0.41 |
Interdialytic weight gain (% of post-dialysis body weight) | 2.52+/−0.86 | 2.64+/− 0.92 | 0.26 |
Pre-dialysis systolic blood pressure [mmHg] | 143.42+/−21.27 | 146.94+/−20.88 | 0.17 |
Serum Sodium [mEq/L] | 135.65+/−1.6 | 135.4+/−2.94 | 0.38 |
Patients with at least 1 hospitalization [yes/no] | 31.39% | 35.77% | 0.52 |
Change in dialysate sodium prescription (intervention)
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
SNa+ [mEq/L] | aligned | 135.80+/−1.35 | 135.77+/−2.57 | −0.03 (−0.48 to 0.42) | −0.12 (−0.60 to 0.36) |
unaligned | 135.76+/−2.47 | 135.80+/−2.8 | 0.09 (−0.48 to 0.66) | ||
GNa+ [mEq/L] | aligned | 0.93+/−1.21 | −0.03+/−2.20 | −0.95 (−1.33 to −0.58) | −0.43 (−0.89 to 0.03) |
unaligned | 1.35+/−2.62 | 0.82+/−2.86 | −0.52 (−1.1 to 0.05) |
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
SNa+ [mEq/L] | aligned | 135.65+/−1.60 | 135.68+/−2.49 | 0.03 (−0.47 to 0.53) | −0.28 (−0.8 to 0.24) |
unaligned | 135.40+/−2.94 | 135.70+/−2.90 | 0.31 (−0.39 to 1.01) | ||
GNa+ [mEq/L] | aligned | 1.35+/−1.60 | −0.41+/−2.11 | −1.76 (−2.21 to −1.31) | −1.45 (−1.98 to −0.91) |
unaligned | 1.6+/−2.94 | 1.29+/−2.94 | −0.31 (−1.01 to 0.39) |
Primary outcomes
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
IDWG [L] | aligned | 2.53+/−0.93 | 2.42+/−0.83 | −0.11 (−0.3 to 0.08) | −0.12 (−0.24 to 0) |
unaligned | 2.67+/−0.97 | 2.7+/−1 | 0.01 (−0.2 to 0.22) | ||
UFV [L] | aligned | 2.44+/−0.86 | 2.32+/−0.76 | −0.12 (−0.3 to 0.06) | −0.15 (−0.25 to −0.04) |
unaligned | 2.58+/−0.96 | 2.6+/−0.9 | 0.03 (−0.18 to 0.23) | ||
Pre HD weight [kg] | aligned | 81.82+/−22.63 | 81.21+/−22.13 | −0.61 (−5.48 to 4.27) | −0.34 (−1.08 to 0.39) |
unaligned | 80+/−21.44 | 79.7+/−20.9 | −0.26 (−4.88 to 4.36) | ||
Post HD weight [kg] | aligned | 79.41+/−22.18 | 78.81+/−21.47 | −0.6 (−5.35 to 4.16) | −0.29 (−1.01 to 0.43) |
unaligned | 77.44+/−20.96 | 77.1+/−20.4 | −0.31 (−4.82 to 4.2) |
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
IDWG [L] | aligned | 2.52+/−0.86 | 2.33+/−0.76 | −0.19 (−0.38 to 0) | −0.18 (−0.3 to −0.05) |
unaligned | 2.64+/−0.92 | 2.60+/−1.0 | −0.01 (−0.24 to 0.21) | ||
UFV [L] | aligned | 2.45+/−0.87 | 2.28+/−0.76 | −0.17 (−0.37 to 0.02) | −0.15 (−0.26 to −0.04) |
unaligned | 2.58+/−0.93 | 2.6+/−0.9 | −0.02 (−0.24 to 0.2) | ||
Pre HD weight [kg] | aligned | 81.29+/−20.67 | 80.48+/−20.17 | −0.8 (−5.66 to 4.06) | −0.39 (−1.13 to 0.35) |
unaligned | 75.36+/−19.3 | 75.0+/−18.70 | −0.41 (−4.93 to 4.11) | ||
Post HD weight [kg] | aligned | 78.84+/−20.16 | 78.22+/−19.80 | −0.61 (−5.36 to 4.14) | −0.2 (−0.92 to 0.53) |
unaligned | 72.82+/−18.9 | 72.4+/−18.30 | −0.42 (−4.84 to 4.0) |
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
Pre HD SBP [mmHg] | aligned | 145.17+/−20.05 | 143.95+/−20.57 | −1.22 (−5.65 to 3.2) | 1.19 (−1.07 to 3.44) |
unaligned | 145.12+/−19.33 | 142.7+/−19.7 | −2.41 (−6.66 to 1.84) | ||
Post HD SBP [mmHg] | aligned | 135.1+/−17.72 | 134.36+/−17.68 | −0.74 (−4.6 to 3.12) | 1.21 (−0.86 to 3.28) |
unaligned | 137.08+/−18.12 | 135.1+/−18.3 | −1.95 (−5.92 to 2.02) | ||
Pre HD DBP [mmHg] | aligned | 74.12+/−12.25 | 73.59+/−12.16 | −0.53 (−3.19 to 2.13) | 0.3 (−0.91 to 1.51) |
unaligned | 75.62+/−11.47 | 74.8+/−11.1 | −0.83 (−3.3 to 1.63) | ||
Post HD DBP [mmHg] | aligned | 69+/−10.39 | 68.83+/−10.49 | −0.17 (−2.45 to 2.1) | 0.43 (−0.67 to 1.53) |
unaligned | 71.39+/−10.21 | 70.8+/−10.1 | −0.6 (−2.82 to 1.61) | ||
Pre HD PP [mmHg] | aligned | 71.06+/−14.92 | 70.36+/−15.52 | −0.69 (−4.01 to 2.62) | 0.89 (−0.59 to 2.36) |
unaligned | 69.5+/−14.11 | 67.9+/−14.9 | −1.58 (−4.74 to 1.58) | ||
Post HD PP [mmHg] | aligned | 66.1+/−12.89 | 65.53+/−13.09 | −0.57 (−3.4 to 2.27) | 0.78 (−0.59 to 2.15) |
unaligned | 65.69+/−13.27 | 64.3+/−13.6 | −1.35 (−4.27 to 1.58) | ||
Pre HD MAP [mmHg] | aligned | 97.8+/−13.58 | 97.04+/−13.64 | −0.76 (−3.73 to 2.21) | 0.6 (−0.88 to 2.08) |
unaligned | 98.79+/−12.96 | 97.4+/−12.7 | −1.36 (−4.16 to 1.44) | ||
Post HD MAP [mmHg] | aligned | 91.03+/−11.82 | 90.67+/−11.81 | −0.36 (−2.94 to 2.21) | 0.69 (−0.66 to 2.04) |
unaligned | 93.29+/−11.83 | 92.2+/−11.8 | −1.05 (−3.63 to 1.52) | ||
Intra HD SBP change [mmHg] | aligned | −10.07+/−13.7 | −9.59+/−13.34 | 0.48 (−2.46 to 3.43) | 0.02 (−2.12 to 2.16) |
unaligned | −8.04+/−13.94 | −7.6+/−13.5 | 0.46 (−2.53 to 3.45) | ||
Intra HD DBP change [mmHg] | aligned | −5.12+/−6.81 | −4.76+/−6.47 | 0.36 (−1.09 to 1.8) | 0.13 (−0.9 to 1.15) |
unaligned | −4.24+/−6.59 | −4+/−6.5 | 0.23 (−1.2 to 1.66) |
Parameter | Study Regimen | Baseline | Follow-up | Difference (95% CI) | Treatment effect (95% CI) |
---|---|---|---|---|---|
Pre HD SBP [mmHg] | aligned | 143.42+/−21.27 | 143.06+/−21.2 | −0.36 (−5.41 to 4.69) | 1.68 (−0.87 to 4.23) |
unaligned | 146.94+/−20.88 | 144.9+/−22 | −2.04 (−7.15 to 3.07) | ||
Post HD SBP [mmHg] | aligned | 132.8+/−16.83 | 133.36+/−17.68 | 0.56 (−3.55 to 4.67) | 1.43 (−0.86 to 3.72) |
unaligned | 137.57+/−19.27 | 136.7+/−19.7 | −0.87 (−5.5 to 3.76) | ||
Pre HD DBP [mmHg] | aligned | 73.23+/−13.03 | 72.99+/−12.65 | −0.24 (−3.3 to 2.81) | 0.43 (−0.94 to 1.8) |
unaligned | 75.9+/−12.16 | 75.2+/−12.1 | −0.67 (−3.56 to 2.21) | ||
Post HD DBP [mmHg] | aligned | 68.14+/−9.59 | 68.23+/−10.13 | 0.09 (−2.26 to 2.44) | 0.34 (−0.91 to 1.58) |
unaligned | 70.97+/−10.62 | 70.7+/−10.3 | −0.25 (−2.74 to 2.24) | ||
Pre HD PP [mmHg] | aligned | 70.19+/−15.3 | 70.07+/−15.6 | −0.12 (−3.79 to 3.56) | 1.25 (−0.4 to 2.9) |
unaligned | 71.05+/−15.24 | 69.7+/−15.9 | −1.37 (−5.07 to 2.34) | ||
Post HD PP [mmHg] | aligned | 64.66+/−13.4 | 65.13+/−13.7 | 0.47 (−2.75 to 3.69) | 1.09 (−0.38 to 2.57) |
unaligned | 66.59+/−13.91 | 66+/−14.4 | −0.62 (−4 to 2.75) | ||
Pre HD MAP [mmHg] | aligned | 96.63+/−14.56 | 96.35+/−14.23 | −0.28 (−3.71 to 3.14) | 0.85 (−0.83 to 2.52) |
unaligned | 99.58+/−13.86 | 98.5+/−14.3 | −1.13 (−4.47 to 2.22) | ||
Post HD MAP [mmHg] | aligned | 89.7+/−10.76 | 89.94+/−11.44 | 0.25 (−2.4 to 2.89) | 0.7 (−0.82 to 2.22) |
unaligned | 93.17+/−12.49 | 92.7+/−12.4 | −0.45 (−3.41 to 2.51) | ||
Intra HD SBP change [mmHg] | aligned | −10.61+/−13.72 | −9.7+/−14.67 | 0.92 (−2.46 to 4.3) | −0.25 (−2.65 to 2.14) |
unaligned | −9.38+/−14.23 | −8.2+/−14.7 | 1.17 (−2.27 to 4.61) | ||
Intra HD DBP change [mmHg] | aligned | −5.09+/−6.8 | −4.76+/−7.3 | 0.33 (−1.34 to 2.01) | −0.09 (−1.24 to 1.05) |
unaligned | −4.92+/−6.98 | −4.5+/−7 | 0.43 (−1.23 to 2.09) |
Secondary outcomes
Aligned | Not Aligned | Aligned versus not aligned | ||||||
---|---|---|---|---|---|---|---|---|
Baseline | Follow-up | Change | Baseline | Follow-up | Change | Difference of changes from baseline to follow-up | ||
Intention to Treat
| ||||||||
All-Cause Hospitalization | Total Admission Length [days] | 3.93+/−8.7 | 3.18+/−6.22 | −0.75 (−2.4 to 0.89) | 6.12+/−13.35 | 5.92+/−10.25 | −0.2 (−2.79 to 2.4) | −0.56 (−3.28 to 2.16) |
Hospitalization Rate [n/patient year] | 1.92+/−3.15 | 1.66+/−2.62 | −0.26 (−0.89 to 0.37) | 2.3+/−3.5 | 2.58+/−3.68 | 0.28 (−0.5 to 1.06) | −0.54 (−1.38 to 0.3) | |
Fluid Overload-related Hospitalization | Total Admission Length [days] | 0.36+/−2.19 | 0.05+/−0.44 | −0.31 (−0.65 to 0.04) | 0.32+/−1.32 | 0.87+/−3.07 | 0.55 (0.03 to 1.06) | −0.85 (−1.47 to −0.23) |
Hospitalization Rate [n/patient year] | 0.17+/−0.78 | 0.04+/−0.34 | −0.13 (−0.26 to 0) | 0.19+/−0.73 | 0.45+/−1.44 | 0.26 (0.01 to 0.51) | −0.39 (−0.67 to −0.12) | |
As Treated
| ||||||||
All-Cause Hospitalization | Total Admission Length [days] | 3.18+/−8.02 | 3.21+/−6.74 | 0.03 (−1.73 to 1.79) | 5.23+/−12.92 | 5.56+/−9.31 | 0.34 (−2.34 to 3.02) | −0.31 (−3.03 to 2.42) |
Hospitalization Rate [n/patient year] | 1.62+/−3.11 | 1.78+/−2.75 | 0.16 (−0.54 to 0.85) | 1.87+/−3.03 | 2.67+/−4 | 0.8 (−0.04 to 1.64) | −0.64 (−1.51 to 0.22) | |
Fluid Overload-related Hospitalization | Total Admission Length [days] | 0.33+/−2.34 | 0.2+/−1.07 | −0.12 (−0.56 to 0.31) | 0.83+/−4.07 | 1.31+/−4.85 | 0.48 (−0.58 to 1.55) | −0.61 (−1.75 to 0.53) |
Hospitalization Rate [n/patient year] | 0.11+/−0.68 | 0.18+/−0.96 | 0.07 (−0.13 to 0.26) | 0.4+/−1.21 | 0.6+/−1.84 | 0.2 (−0.17 to 0.57) | −0.13 (−0.53 to 0.27) |