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Table 4 Laboratory parameters in the safety population

From: The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation

Parameter Statistic Screening Week 1 Week 2
Patient number (Safety Population) N 11 11 10
Erythrocytes (10^12/L) Mean (SD) 4.0 (0.58) 3.6 (0.52) 3.4 (0.57)
Median 4.1 3.7 3.6
Min, Max 2.8, 4.7 2.9, 4.3 2.4, 4.0
Leukocytes (10^9/L) Mean (SD) 8.3 (5.45) 7.1 (2.70) 5.8 (1.94)
Median 6.9 6.4 5.6
Min, Max 3.1, 23.9 3.7, 13.4 2.6, 8.5
Hematocrit (%) Mean (SD) 37.5 (4.57) 34.1 (3.79) 31.7 (4.14)
Median 37.9 34.3 31.8
Min, Max 28.9, 43.2 28.9, 40.5 23.8, 36.4
Hemoglobin (g/dL) Mean (SD) 11.8 (1.56) 10.9 (1.27) 10.1 (1.38)
Median 12 10.8 10
Min, Max 9.0, 13.8 9.3, 12.7 7.6, 11.8
MCH (pg/cell) Mean (SD) 30.1 (2.42) 30.2 (2.35) 29.8 (2.62)
Median 30.8 30.7 30.1
Min, Max 23.8, 32.5 24.1, 33.1 23.5, 32.5
MCHC (g/dL) Mean (SD) 31.6 (0.98) 32.0 (0.97) 31.8 (1.24)
Median 31.7 32.1 31.8
Min, Max 29.6, 33.4 29.7, 33.2 29.1, 33.3
MCV (fL) Mean (SD) 95.2 (6.15) 94.2 (5.94) 93.7 (6.03)
Median 95.4 94.3 93.5
Min, Max 80.6, 104.3 80.9, 102.1 80.6, 101.3
RDW (%) Mean (SD) 14.8 (1.36) 14.8 (1.44) 14.3 (1.09)
Median 14.5 14.3 14
Min, Max 12.7, 18.0 13.0, 17.9 13.3, 16.5
Platelets (10^9/L) Mean (SD) 251.6 (117.6) 220.8 (85.90) 205.8 (97.71)
Median 227 192 171
Min, Max 159.0, 501.0 143.0, 396.0 101.0, 450.0
MPV (fL) Mean (SD) 10.6 (0.84) 10.9 (1.01) 11.0 (0.94)
Median 10.4 10.5 11.1
Min, Max 9.5, 12.2 9.1, 12.4 9.3, 12.4
Absolute Basophils (10^9/L) Mean (SD) 0.0 (0.04) 0.0 (0.04) 0.0 (0.03)
Median 0 0 0
Min, Max 0.0, 0.1 0.0, 0.1 0.0, 0.1
Absolute Eosinophils (10^9/L) Mean (SD) 0.2 (0.13) 0.2 (0.11) 0.2 (0.11)
Median 0.1 0.2 0.1
Min, Max 0.1, 0.4 0.1, 0.4 0.1, 0.4
Absolute Lymphocytes (10^9/L) Mean (SD) 2.0 (1.03) 1.7 (0.53) 1.6 (0.73)
Median 1.7 1.7 1.6
Min, Max 0.7, 4.3 0.9, 2.5 0.6, 2.9
Absolute Monocytes (10^9/L) Mean (SD) 0.6 (0.38) 0.7 (0.34) 0.5 (0.18)
Median 0.5 0.6 0.5
Min, Max 0.3, 1.7 0.3, 1.5 0.2, 0.8
Absolute Neutrophils (10^9/L) Mean (SD) 5.4 (4.30) 4.5 (2.45) 3.5 (1.31)
Median 4.4 3.8 3.6
Min, Max 2.0, 17.7 2.1, 10.5 1.7, 5.7
Percent Basophils (%) Mean (SD) 0.4 (0.24) 0.6 (0.35) 0.6 (0.40)
Median 0.3 0.6 0.5
Min, Max 0.2, 1.0 0.1, 1.3 0.1, 1.5
Percent Eosinophils (%) Mean (SD) 2.5 (1.78) 2.9 (1.35) 2.8 (1.23)
Median 1.9 2.9 2.2
Min, Max 0.5, 5.7 1.3, 4.9 1.7, 5.3
Percent Lymphocytes (%) Mean (SD) 25.6 (9.02) 25.2 (7.76) 27.6 (7.32)
Median 24.9 24.9 27.8
Min, Max 11.7, 39.5 12.3, 36.1 15.8, 38.1
Percent Monocytes (%) Mean (SD) 8.0 (2.47) 10.2 (5.97) 9.5 (3.26)
Median 7 8.1 8.8
Min, Max 5.9, 13.8 4.6, 24.8 5.2, 17.0
Percent Neutrophils (%) Mean (SD) 63.4 (11.25) 61.1 (8.92) 59.6 (7.16)
Median 64.5 56.9 61.5
Min, Max 44.6, 78.9 51.2, 78.5 44.6, 67.1
Sodium (mmol/L) Mean (SD) 141.1 (3.11) 141.0 (2.65) 141.1 (2.39)
Median 141 141 141
Min, Max 136.0, 149.0 138.0, 147.0 137.0, 144.0
Potassium (mmol/L) Mean (SD) 4.8 (0.50) 4.8 (0.35) 4.5 (0.44)
Median 4.9 4.8 4.4
Min, Max 3.8, 5.5 4.1, 5.4 3.8, 5.2
Chloride (mmol/L) Mean (SD) 96.2 (4.79) 98.4 (4.30) 97.5 (5.26)
Median 96 97 99
Min, Max 88.0, 102.0 93.0, 106.0 89.0, 106.0
BUN (mg/dL) Mean (SD) 36.7 (16.33) 45.8 (15.06) 41.3 (17.87)
Median 33 46 36
Min, Max 16.0, 69.0 27.0, 83.0 20.0, 82.0
Creatinine (mg/dL) Mean (SD) 7.0 (1.46) 8.1 (1.25) 7.9 (1.06)
Median 6.5 7.9 8.3
Min, Max 4.6, 9.5 6.4, 10.8 6.4, 9.4
BUN/Creatinine (RATIO) Mean (SD) 5.2 (1.89) 5.7 (2.00) 5.0 (2.36)
Median 5 5 4.5
Min, Max 2.0, 9.0 3.0, 10.0 2.0, 10.0
Glucose (mg/dL) Mean (SD) 125.1 (56.33) 139.3 (50.78) 151.9 (56.93)
Median 89 118 130.5
Min, Max 78.0, 223.0 84.0, 221.0 97.0, 237.0
Calcium (mg/dL) Mean (SD) 9.3 (0.65) 8.9 (0.50) 8.7 (0.57)
Median 9.3 9 8.8
Min, Max 8.3, 10.8 8.0, 9.8 7.9, 9.5
Protein (g/dL) Mean (SD) 7.4 (0.42) 6.7 (0.50) 6.5 (0.42)
Median 7.4 6.8 6.5
Min, Max 6.6, 8.1 6.0, 7.8 5.9, 7.5
Globulin (g/dL) Mean (SD) 3.0 (0.34) 2.7 (0.26) 2.6 (0.25)
Median 2.9 2.8 2.6
Min, Max 2.3, 3.5 2.4, 3.2 2.3, 3.2
Albumin (g/dL) Mean (SD) 4.4 (0.32) 4.0 (0.33) 3.9 (0.28)
Median 4.3 4.1 3.9
Min, Max 3.8, 4.9 3.4, 4.6 3.4, 4.3
A/G Ratio (RATIO) Mean (SD) 1.5 (0.23) 1.5 (0.14) 1.5 (0.14)
Median 1.4 1.5 1.5
Min, Max 1.2, 2.0 1.2, 1.6 1.3, 1.7
Albumin/Total Protein (RATIO) Mean (SD) 0.6 (0.06) 0.6 (0.00) 0.6 (0.00)
Median 0.6 0.6 0.6
Min, Max 0.5, 0.7 0.6, 0.6 0.6, 0.6
ALP (ukat/L) Mean (SD) 95.4 (37.60) 88.5 (35.42) 79.2 (32.93)
Median 94 83 79
Min, Max 42.0, 160.0 40.0, 146.0 39.0, 139.0
ALT (ukat/L) Mean (SD) 15.1 (5.32) 15.4 (9.25) 11.6 (5.06)
Median 13 12 10.5
Min, Max 9.0, 26.0 6.0, 32.0 6.0, 22.0
AST (ukat/L) Mean (SD) 15.8 (6.15) 15.9 (8.23) 15.8 (5.17)
Median 14 15 17
Min, Max 8.0, 25.0 5.0, 30.0 9.0, 23.0
Bilirubin (umol/L) Mean (SD) 0.4 (0.18) 0.3 (0.10) 0.3 (0.12)
Median 0.4 0.3 0.3
Min, Max 0.2, 0.7 0.2, 0.5 0.2, 0.6
spKt/V Mean (SD) NA 1.9 (0.38) 1.9 (0.36)
Median NA 1.9 1.8
Min, Max NA 1.4, 2.6 1.4, 2.4