β2M Post-HD Rebound Prediction
Predicting the Post-dialysis Rebound of β2-microglobulin
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 Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude.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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Shaza Adam, Clinical research Fellow
- 전화번호: 01438287884340 00447365073834
- 이메일: Shaza.adam@nhs.net
연구 연락처 백업
- 이름: Enric Vilar, Consultant Nephrologist and Se
- 이메일: enric.vilar@nhs.net
연구 장소
-
-
-
Stevenage, 영국, SG1 4AB
- 모병
- East and North Hertfordshire NHS Trust
-
연락하다:
- Toral Odedra, Research Sponsorship Coordinat
- 이메일: grantapplications.enh-tr@nhs.net
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age 18 years or above.
- Ability to give informed consent.
- End Stage Renal Disease established on maintenance haemodialysis for at least 3 months
Exclusion Criteria:
- Inability to give informed consent.
- Acute infection in last 2 weeks.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
End Stage Renal Disease on haemodialysis
Adult, End Stage Renal Disease established on maintenance haemodialysis for at least 3 months
|
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 next routine haemodialysis session, which is second and last study visit. All study samples will be used to measure β2-Microglobulin concentration in mg/L |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Post-dialysis β2-microglobulin blood concentration (mg/L) at 1 and 2 hours after completion of haemodialysis
기간: The study is very short study (Over 2 days)
|
β2-microglobulin blood samples will be collected at time points including pre-dialysis (0%), at 20%, 40%, 60%, 80%, and 100% of the dialysis session, as well as at 1 hour and 2 hours post-dialysis. An additional pre-dialysis sample will be obtained before the next routine haemodialysis session (approximately 48 hours later). The primary outcome measure will be the β2-microglobulin concentration (mg/L) at 1 and 2 hours post-dialysis, which will serve as the dependent variable in regression-based and software-assisted modelling. These models will be used to develop an algorithm capable of accurately predicting the equilibrated post-dialysis β2-microglobulin concentration from measurements obtained during the dialysis session. |
The study is very short study (Over 2 days)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
We will record small panel of solute clearance markers such as blood urea measured in mmol/L and creatinine umol/L
기간: The study is very short study (Over 2 days)
|
This is recorded from the standard of care blood tests assessing monthly dialysis adequacy.
Derived from routine monthly dialysis adequacy testing done at same time period of the study sample collection.
|
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
기간: The study is very short study (Over 2 days)
|
The following validated Questionnaires will be used to assess Patient Reported Outcome Measure (PROM): SONG-HD Fatigue, Recovery time and IPOS Renal questionnaires . The questionnaire burden was discussed at the Patients and Public Involvement Group meeting within the trust and considered in study design. The questionnaires were considered relevant and the burden on patients was judged to be acceptable and not a major barrier to participation. To minimise the participants being overwhelmed with questionnaires, we will offer them flexibility of completing the questionnaires during and or after first study visit (either on dialysis or at home). They may also receive support from family, friend and or medical staff team to help filling these questionnaires as needed. It is anticipated that each questionnaire will take approximately 5 minutes to complete. We expect most patients will complete this during their dialysis treatment |
The study is very short study (Over 2 days)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Shaza Adam, Lister Hospital, East and North Hertfordshire Teaching NHS Trust
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RD2025-60
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .