Protein-Bound Uremic Retention Solutes in Long Nocturnal Hemodialysis
A Multicentric Observational Study on the Removal of Protein-Bound Uremic Retention Solutes in Nocturnal Hemodialysis: A Cross-Sectional Analysis
Although remarkable progress has been made, chronic kidney disease still poses a major burden on both individual patients, as well as on society as a whole. There is a strong inverse relationship between decreasing renal function, as estimated by glomerular filtration rate, and mortality rate, especially death due to cardiovascular disease. The exact cause(s) remain to be elucidated. Uremic toxins might play an important role.
In the course of decreasing renal function the concentration of numerous intracellular and extracellular compounds vary from the non-uremic state. But still increasing number of uremic retention solutes are being identified. Renal replacement strategies aim to remove potentially harmful substances from the body. Traditionally much attention has been paid to small water-soluble molecules such as urea nitrogen and creatinine. Based on the results of the recent HEMO and ADEMEX studies, increases of small water-soluble solute removal above the level reached with modern dialysis techniques - hemodialysis, peritoneal dialysis (HD, PD) - seem not to be advantageous with regard to patient outcome. These findings may point to the importance of other distinct groups of uremic retention solutes. In view of the data described above, protein-bound solutes might be good candidates.
Several advantages of long duration hemodialysis have been observed, including a better control of blood pressure by decreasing extracellular fluid volume, lowering peripheral vascular resistance and improving endothelium-dependent and -independent vasodilation. A normalization of heart rate variability and improvement of left-ventricular function was noted as well. Furthermore, anemia control has been shown to be easier and several nutritional parameters improved in patients treated with long duration HD. The therapy results in higher small water-soluble solute removal, phosphate removal and greater elimination of larger molecules (e.g. β2-microglobulin).
It seems an appealing question whether a better control of the serum levels of protein-bound solutes can be achieved by long duration (nocturnal) hemodialysis. This might be another advantage of this therapeutic modality, or may even in part explain the better outcome of patients treated this way.
The study compares intermittent hemodialysis with long nocturnal hemodialysis with respect to serum concentrations of several protein bound uremic toxins, as well as solute removal.
調査の概要
研究の種類
入学 (実際)
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age > 18 years
- Maintenance hemodialysis (> 3 months duration)
- Informed consent
Exclusion Criteria:
- No consent
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:ケースのみ
- 時間の展望:見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
1
hemodialysis twice weekly 4 hours
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
2
nocturnal dialysis twice weekly 8 hours
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
3
nocturnal hemodialysis, 8 hours every other night
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
4
nocturnal hemodialysis, 8 hours, six times per week
|
group 1: twice weekly, four hours
group 2: twice weekly, eight hours
group 3: every other day, eight hours
group 4: six days a week, eight hours
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
removal of protein-bound retention solutes
時間枠:1 dialysis session
|
1 dialysis session
|
協力者と研究者
捜査官
- 主任研究者:Tom Dejagere, MD、Virga Jesse Ziekenhuis
- 主任研究者:Nigel Toussaint, MD、Geelong Hospital
出版物と役立つリンク
一般刊行物
- Bammens B, Evenepoel P, Keuleers H, Verbeke K, Vanrenterghem Y. Free serum concentrations of the protein-bound retention solute p-cresol predict mortality in hemodialysis patients. Kidney Int. 2006 Mar;69(6):1081-7. doi: 10.1038/sj.ki.5000115.
- Fagugli RM, De Smet R, Buoncristiani U, Lameire N, Vanholder R. Behavior of non-protein-bound and protein-bound uremic solutes during daily hemodialysis. Am J Kidney Dis. 2002 Aug;40(2):339-47. doi: 10.1053/ajkd.2002.34518.
- Pierratos A. Daily nocturnal home hemodialysis. Kidney Int. 2004 May;65(5):1975-86. doi: 10.1111/j.1523-1755.2004.00603.x. No abstract available.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
hemodialysisの臨床試験
-
Xeltis募集末期腎臓病スペイン, イタリア, ベルギー, ラトビア, ポルトガル, ドイツ, ギリシャ, イギリス, ポーランド