Theranova vs High-flux HD Comparison
關鍵詞
抽象
描述
Accumulation of uremic toxins is associated morbidity and mortality in patients with end-stage renal disease, but the pathogenic mechanisms how they lead to various clinical complications remain elusive. Conventional hemodialysis is effective in removing small molecular solutes (in the range of 50-15,000 Da), but the removal of protein-bound and middle to larger molecular toxins (up to 50,000 Da) remains unsatisfactory even with augmented hemodialysis frequency or duration. The notion that dialysis adequacy is no longer a simple quantitative measure of small molecular removal has led to the clinical application of intensive hemodialysis and the search for novel strategies to reduce uremic toxin burden.
Recently, a new class of membrane with molecular weight cut off (MWCO) close to the molecular weight of albumin was introduced. The focus of this new therapy, known as expanded dialysis using the medium cut off (MCO) dialysis membrane, is to provide the potential for more efficient removal of middle molecules and protein bound uremic toxins without excessive loss of albumin. To date, MCO dialysis has been associated with a reduction in transcription of pro-inflammatory cytokines (i.e. interleukin 6 and tumor necrosis factor-α) and middle molecules especially free lambda light chains.
Protein-energy wasting and cardiovascular diseases are prevalent in chronic kidney disease and is related to inflammation and increased mortality. Despite growing data on the clearance of individual uremic toxins and biochemical parameters, the impact of MCO dialysis on clinical outcomes and mechanistic parameters related to nutrition and inflammation remains to be investigated.
The objective of the study is to compare MCO dialysis with conventional high-flux HD, on nutritional parameters, inflammation and cardiovascular biomarkers and related clinical outcomes.
Since twice-weekly HD is commonly practiced in Hong Kong, this study provides a distinct opportunity to investigate whether MCO dialysis might be particularly advantageous in patients receiving a relatively lower dialysis dose through the removal of a broader spectrum of uremic toxins.
The investigators hypothesize that MCO dialysis with Theranova Dialyzer (HDx) improves parameters related to nutrition and inflammation compared with high-flux HD.
This will be a prospective single-blinded, randomized, controlled trial with stable HD patients randomized at 1:1 ratio to either one of the following - A. to continue with HD using the same high-flux dialyzer as in the previous 6 weeks (high-flux HD arm) B. change to HDx using Theranova Dialyzer (MCO dialysis arm)
日期
| 最後驗證: | 03/31/2020 |
| 首次提交: | 09/09/2019 |
| 提交的預估入學人數: | 09/23/2019 |
| 首次發布: | 09/26/2019 |
| 上次提交的更新: | 04/05/2020 |
| 最近更新發布: | 04/07/2020 |
| 實際學習開始日期: | 10/31/2019 |
| 預計主要完成日期: | 06/29/2021 |
| 預計完成日期: | 12/30/2021 |
狀況或疾病
干預/治療
Device: High-flux
Device: Theranova
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Active Comparator: Theranova Patients will be receiving hemodialysis using Theranova dialyzer. The other hemodialysis parameters are kept the same. | Device: Theranova a middle cut-off dialyzer |
| Active Comparator: High-flux Patients will be receiving hemodialysis using a high-flux dialyzer. The other hemodialysis parameters are kept the same | Device: High-flux a dialyzer meeting the definition of high-flux |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: - adult patients age greater than 18 years old - end-stage renal failure on two- or three-times per week high-flux HD for more than 90 days - mean spKt/Vurea >1.2 per session (for 3 dialysis sessions per week) or spKt/Vurea >1.8 per session (for 2 dialysis sessions per week) Exclusion Criteria: - active malignancy - unable to give informed consent or complete questionnaires - unstable clinical condition defined as significant clinical event requiring hospitalization in the past 90 days - unreliable vascular access - unable to achieve HD blood flow >150ml/min |
結果
主要結果指標
1. lean tissue index [12 months]
2. Body Mass Index [12 months]
次要成果指標
1. asymmetrical dimethylarginine [12 months]
2. fibroblast growth factor 23 [12 months]
3. Klotho [12 months]
4. Kt/V urea [12 months]
5. beta-2 microglobulin [12 months]
6. Pentraxin-3 [12 months]
7. soluble endothelial protein C receptor [12 months]
8. soluble thrombomodulin [12 months]
9. hemoglobulin [12 months]
10. high-sensitive C reactive protein [12 months]
11. interleukin 6 [12 months]
12. tumor necrosis factor alpha [12 months]
13. albumin [12 months]
14. Leptin [12 months]
15. adiponectin [12 months]
16. phosphate [12 months]
17. low-density lipoprotein [12 months]
18. high-density lipoprotein [12 months]
19. triglyceride [12 months]
20. Malnutrition-Inflammation Score [12 months]
21. Subjective Global Assesment questionnaire [12 months]
22. fat tissue index [12 months]
23. admission rate due to cardiovascular events [12 months]
24. admission rate due to infection [12 months]
25. mortality rate [12 months]
26. 5-D itch scale [12 months]
27. Numeric rating scale for itchiness [12 months]
28. The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score [12 months]
29. Visual analogue scale for appetite [12 months]
30. Postdialysis recovery time [12 months]
31. Self-reported sleep quality [12 months]
32. Hong Kong Montreal Cognitive Assessment [12 months]
33. KDQOLSFTMv1.3 questionnaire [12 months]
34. DNA methylation analysis of TRPV1 gene [12 months]
35. DNA methylation analysis of LY96 gene [12 months]
36. DNA methylation analysis of IFNGR1 gene [12 months]
