Table 3.
Extended endpoint analysis—single session and long-term comparison of MCO versus high flux.
| High flux (mean ± SD) | MCO | LMM-4 h | LMM-0 h | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 0 h | 4 h | P | 0 h | 4 h | P | Est. | P | Est. | P | |
| MCP-1 | 86.4 ± 43.8 | 74.1 ± 42.1 | 0.001 | 81.6 ± 45.0 | 69.5 ± 37.8 | 0.009 | − 1.7 | 0.82 | 5.8 | 0.11 |
| YKL-40 | 593 ± 419 | 564 ± 422 | 0.25 | 563 ± 376 | 360 ± 334 | < 0.001 | − 223 | < 0.001 | 3.9 | 0.89 |
| IL-8 | 11.4 ± 6.1 | 10.6 ± 6.0 | 0.16 | 11.3 ± 6.0 | 10.7 ± 10.0 | 0.69 | − 1.1 | 0.10 | 3.94 | 0.54 |
| IP-10 | 57.4 ± 47.1 | 97.9 ± 92.3 | 0.001 | 58.1 ± 62.2 | 91.6 ± 73.8 | < 0.001 | − 16.6 | 0.009 | 1.0 | 0.84 |
| TNFα | 55.8 ± 201.6 | 588 ± 2629 | 0.22 | 28.7 ± 133.8 | 99.6 ± 491.3 | 0.21 | 606 | 0.45 | 46.2 | 0.35 |
| IL-6 | 7.8 ± 15.5 | 8.1 ± 7.6 | 0.86 | 7.1 ± 6.3 | 8.2 ± 7.2 | 0.16 | 0.5 | 0.56 | − 1.9 | 0.25 |
| IL-12 | 0.2 ± 0.5 | 0.3 ± 0.7 | 0.28 | 0.2 ± 0.5 | 0.3 ± 0.7 | 0.03 | − 0.02 | 0.60 | 0.04 | 0.098 |
| Eotaxin | 41.1 ± 24.0 | 45.5 ± 29.9 | 0.22 | 37.7 ± 18.5 | 39.9 ± 19.1 | 0.24 | 4.44 | 0.02 | 0.8 | 0.63 |
| RANTES | 1339 ± 726 | 2454 ± 1391 | < 0.001 | 1224 ± 722 | 2065 ± 1266 | < 0.001 | − 75 | 0.68 | − 124 | 0.22 |
| IL-10 | 303 ± 628 | 3703 ± 20,128 | 0.31 | 214 ± 593 | 402 ± 808 | 0.002 | 5242 | 0.39 | − 17 | 0.73 |
| MIG | 1029 ± 2027 | 853 ± 2184 | 0.04 | 1002 ± 3037 | 418 ± 1304 | 0.04 | − 399 | < 0.001 | 119 | 0.45 |
| IL-4 | 6.0 ± 21.4 | 17.2 ± 89.0 | 0.34 | 2.9 ± 12.2 | 10.1 ± 61.2 | 0.35 | − 7.3 | 0.11 | 2.1 | 0.45 |
| IL-13 | 0.3 ± 0.8 | 0.4 ± 1.5 | 0.44 | 0.3 ± 0.8 | 0.4 ± 1.4 | 0.61 | − 0.1 | 0.30 | 0.06 | 0.37 |
| IL-1β | 50.9 ± 220 | 70.8 ± 220 | 0.13 | 23.7 ± 63.0 | 31.0 ± 75.3 | 0.59 | − 56 | 0.13 | 45.4 | 0.2 |
| Kt/V * | 1.66 ± 0.54 | – | 1.53 ± 0.31 | – | − 0.03 | 0.62 | – | |||
The table reports mean ± standard deviation (SD) of inflammatory mediators as specified in the left column during MCO versus high flux treatment at T1 and T3—intention to treat population (n = 42 and n = 37 patient × treatment pairs respectively). Interleukin concentrations were assayed as follows: TNFα, IL-10, IL-4, IL-13, IL-1β: fg/ml; MCP-1, IL-8, IP-10, IL-6, Il-12, Eotaxin, RANTES, MIG, IL-4: pg/ml; YKL-40: pg/ml. Pre-versus post-dialysis intra-individual decline or increase was assessed using paired-t-tests within the treatment arms and 0 h and 4 h serum mediator levels, respectively. In the right two columns results from linear mixed effects models (LMM) [using subject ID, nested in sequence as a random effect and treatment (MCO = 1), period and sequence as the main effects] are displayed for post-HD (4 h) values and pre-HD (0 h) values, respectively. Herein, the 4 h LMM compares single session kinetics, whereas the 0 h model tests for long term differences (over a period of 3 months).
Estimate (Est.); Eosinophil chemotactic protein (EOTAXIN), *Kt/V was calculated according to Daugirdas = − ln((Post BUN/Pre BUN) − (0.008 × Dialysis duration)) + (4 − 3.5 × (Post BUN/Pre BUN)) × (UF/Weight). Data for calculation of means was used at T1 and T3—intention to treat population (n = 31 and n = 22 patient × treatment pairs respectively); Interleukin (IL); Interferon-inducible protein 10 (IP-10); Monocyte Chemoattractant Protein-1 (MCP-1); Regulated on Activation, Normal T Expressed and Secreted (RANTES, a.k.a. CCL5); Tumor Necrosis Factor alpha (TNFα).