Table 2. Patient characteristics.
| Characteristic | TaurolockU N = 36 | TaurolockHEP N = 32 | P-value2 |
|---|---|---|---|
| Age–yr (mean ± SD) | 72.3 ± 13.8 | 73.2 ± 12.2 | 0.794 |
| Female sex–n (%) | 16 (44.4) | 19 (59.4) | 0.236 |
| Cause of end-stage renal disease–n (%) | 0.370 | ||
| Diabetic nephropathy | 11 (30.5) | 9 (28.1) | |
| Hypertensive or vascular nephropathy | 19 (52.8) | 10 (31.3) | |
| Glomerulonephritis | 1 (2.8) | 3 (9.4) | |
| Polycystic renal disease | 1 (2.8) | 3 (9.4) | |
| Tubulo-interstitial disease | 1 (2.8) | 2 (6.3) | |
| Unknown | 3 (8.3) | 5 (15.6) | |
| Duration of dialysis–yr (median, IQR) | 2.7 (1.1–4.5) | 4.40 (1.8–8.3) | 0.01 |
| Catheter (last) vintage—days (median, IQR) | 542 (231–1277) | 533 (263–921.5) | 0.716 |
| Catheter localization–n (%) | 0.470 | ||
| Right internal jugular vein | 29 (80.6) | 23 (71.9) | |
| Left internal jugular vein | 7 (19.4) | 8 (25.0) | |
| Subclavian vein | 0 (0) | 1 (3.1) | |
| History of catheter removal for thrombosis–n (%) | 10 (27.8) | 9 (30.0) | 0.606 |
| Number of catheters removed—n (%) | 0.454 | ||
| 1 | 5 (50.0) | 7 (77.8) | |
| 2 | 3 (30.0) | 1 (11.1) | |
| 3 | 0 (0) | 1 (11.1) | |
| 4 | 1 (10.0) | 0 (0) | |
| 5 | 1 (10.0) | 0 (0) | |
| History of AVF/AVG failure due to thrombosis | 6 | 5 | 0.925 |
| Number of episodes—n (%) | |||
| 1 | 4 (11.1) | 5 (15.6) | |
| 2 | 1 (2.8) | 0 (0) | |
| 3 | 1 (2.8) | 0 (0) | |
| Number of urokinase locks per patient in the 6m before inclusion–(median; 95% CI) | 3.06 (2.34–3.77) | 3.63 (2.82–4.43) | 0.283 |
| Comorbidity–n (%)1 | |||
| Diabetes | 18 (50.0) | 14 (43.8) | 0.606 |
| Arterial hypertension | 33 (91.7) | 28 (87.5) | 0.699 |
| Peripheral vascular disease | 10 (27.8) | 6 (18.8) | 0.408 |
| Ischemic cardiomyopathy | 15 (41.7) | 10 (31.3) | 0.374 |
| Deep venous thrombosis | 1 (2.8) | 3 (9.4) | 0.336 |
| Pulmonary embolism | 2 (5.6) | 1 (3.1) | 1 |
| Active neoplasia | 4 (11.1) | 1 (3.1) | 0.360 |
| Medications at inclusion–n (%) | |||
| Aspirin | 21 (58.3) | 17 (53.1) | 0.666 |
| Clopidogrel | 2 (5.6) | 2 (6.3) | 1 |
| Warfarin | 6 (16.7) | 7 (21.9) | 0.759 |
| Low molecular weight heparin | 2 (5.6) | 1 (3.1) | 1 |
| Anticoagulation during hemodialysis—n (%) | 0.524 | ||
| Anticoagulation free hemodialysis | 0(0) | 1(3.1) | |
| Unfractionated heparin during hemodialysis | 22 (61.1) | 22 (68.8) | |
| Low molecular weight heparin during hemodialysis | 11 (30.6) | 6 (18.8) | |
| Other | 3 (8.3) | 3 (9.4) | |
| Hemodialysis modality–n (%) | 0.865 | ||
| Hemodialysis high flux | 30 (83.3) | 26 (81.3) | |
| Hemodiafiltration (post-dilution) | 6 (16.7) | 5 (15.6) | |
| Hemodiafiltration (mid-dilution) | 0 (0) | 1 (3.1) | |
| Hemodialysis duration—min (median, smallest and largest time) | 240 (180–240) | 240 (210–240) | 0.118 |
| Locking solution at inclusion | 1 | ||
| Taurolock HEP500 | 34 (94.4) | 30 (93.8) | |
| Sodium citrate | 1 (2.8) | 1 (3.1) | |
| Heparin | 1 (2.8) | 1 (3.1) | |
| Baseline catheter blood flow (mean ± SD; ml/min) | 300±23 | 297±26 | 0.61 |
| Serum albumin (mean ± SD; g/l) | 36.5±4.5 | 36.7±5.2 | 0.89 |
| Baseline URR at inclusion (mean ± SD; %) | 72.4 ±7.9 | 73.5±9.5 | 0.60 |
| Baseline Kt/V at inclusion (mean ± SD) | 1.45±0.3 | 1.49±0.3 | 0.56 |
| Platelet count–(mean ± SD; x103/l) | 211.6±86.2 | 209.8±85.1 | 0.93 |
| Hemoglobin level (mean ± SD; g/dl) | 10.7±1.1 | 10.5±1.2 | 0.49 |
| C-reactive protein (mean ± SD; mg/l) | 12±14.1 | 10.7±15.1 | 0.71 |
| EPO dosis–IU/Kg/week (median, 95% CI) | 81.5 (0–129.5) | 74 (0–138) | 0.96 |
Abbreviations: SD, standard deviation; IQR, interquartile range; AVF, arterio-venous fistula; AVG, arterio-venous graft; URR, ureum reduction rate.
1 Some comorbidities may be additive in the same patient.
2 Due to randomization P values are not provided to test the null hypothesis but to inform whether groups differed by chance more than expected based on a type I error of 5%.