β2M Post-HD Rebound Prediction

Официальное название

Predicting the Post-dialysis Rebound of β2-microglobulin

Обзор

β2-Microglobulin is small 11.8 kDa protein presents on the surface of all nucleated cell in the human body, it forms part of the non-variable chain of Major Histocompatibility Complex class I. β2-Microglobulin production is constant and it is continuously released into the bloodstream. Its production increases during active infections, inflammation or blood cancers. The Kidneys are the main route of its elimination. It accumulates in patients with kidney disease and levels can rise significantly in patients with end-stage renal failure. Studies have shown that its accumulation in dialysis patients contributes to dialysis-related amyloidosis. Haemodialysis is a significant contributor to removal of β2-microglobulin in those on dialysis. It removes β2-microglobulin from the blood rather than directly from tissues. Blood levels fall during dialysis. However, after haemodialysis, β2-microglobulin gradually moves from tissues into the bloodstream until equilibrium is reached (post-dialysis rebound). Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude. β2-Microglobulin is increasingly recognized as an important marker of middle-molecule solute clearance. The investigators plan to recruit thirty haemodialysis patients. During two dialysis sessions blood samples will be taken to measure β2-microglobulin. During the first session, samples will be taken pre-dialysis and at intervals during the session. Post-dialysis samples will be taken at 1 and 2 hour time points. The investigators will perform a physical examination, fluid/nutrition assessment. Dialysis prescription and routine monthly blood and urine results will also be recorded, and patients will be asked to complete questionnaires about dialysis symptoms, fatigue and post-dialysis recovery time. At the start of the next dialysis, one final β2-microglobulin sample will be taken. β2-microglobulin removal may be a useful marker of dialysis quality. The investigators aim to develop a predictive model to estimate the equilibrated β2-microglobulin to allow its dialysis clearance to be accurately assessed.

Вмешательства

• Диагностический тест β2-microglobulin blood concentration in mg/L
  Blood samples for β2-microglobulin measurement will be collected by study investigator across two haemodialysis sessions. During the first study visit (HD1), blood samples will be obtained pre-dialysis (0%), at 20%, 40%, 60%, and 80% of the prescribed dialysis duration, at the end of dialysis (100%), and at 1 hour and 2 hours following completion of dialysis. During the second study visit (HD2), a single pre-dialysis β2-microglobulin sample will be collected at the start of the participant's nex

Первичные конечные точки

• Post-dialysis β2-microglobulin blood concentration (mg/L) at 1 and 2 hours after completion of haemodialysis [Срок оценки: The study is very short study (Over 2 days)]

Вторичные конечные точки (2)

• We will record small panel of solute clearance markers such as blood urea measured in mmol/L and creatinine umol/L [Срок оценки: The study is very short study (Over 2 days)]
• We will assess Patient-Reported Outcome Measures (PROMs) related to dialysis quality and dialysis-associated symptom burden, using validated questionnaires [Срок оценки: The study is very short study (Over 2 days)]

Критерии участия

Критерии включения

• Age 18 years or above.
• Ability to give informed consent.
• End Stage Renal Disease established on maintenance haemodialysis for at least 3 months

Критерии исключения

• Inability to give informed consent.
• Acute infection in last 2 weeks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• East and North Hertfordshire NHS Trust — Stevenage

Идентификаторы

NCT: NCT07713680 · RD2025-60

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗