A Study of Novel Biomarkers of Kidney Dysfunction in Patients Admitted for Liver Transplant Assessment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Relationship between pre-transplant kidney function using novel biomarkers and post-transplant morbidity and mortality.
研究概览
简要总结
Kidney dysfunction before and immediately after liver transplantation is common and leads to poorer outcomes, including prolonged need for post-operative intensive care, diminished graft survival, and greater risk of permanent kidney dysfunction and death. Blood creatinine level - the standard measure of kidney function - is suboptimal in people with advanced liver disease, overestimating kidney function by >20%. There is significant concern that liver transplant recipients are at higher risk of acute kidney injury (AKI) than we can currently predict. This study aims to identify superior tests (blood/urine or imaging) for kidney dysfunction, to enable improved treatment and patient outcomes.
This study aims to recruit 80-100 consecutive patients admitted to the Scottish Liver Transplant Unit (SLTU), Royal Infirmary of Edinburgh (RIE) for liver transplant assessment over a 6 month period. Permission will be sought to record the results of routine tests performed by the NHS during this assessment week. These tests include: electrocardiograph (ECG), Computed Tomography (CT) liver and abdomen, cardio-pulmonary exercise testing (CPEX), pulmonary function tests (PFTS), routine haematology and biochemistry blood tests, 24 hour urine collection and body composition analysis.
In addition, we will invite participants to attend the RIE clinical research facility (CRF) for a single visit (~2 hours) to perform extra research assessments. Blood and urine will be collected for biomarker analysis. Non-invasive assessment of cardiovascular function will be completed using cardiac bio-impedance and aortic pulse wave velocity. Examination of the blood vessels at the back of the eye will be performed using optical coherence tomography.
A subgroup of 10 participants will undergo magnetic resonance imaging (MRI) of the kidneys using arterial spin labelling to identify dysregulated renal perfusion. Patients who are transplanted during the study timeframe will be asked to re-attend the CRF for repeat assessments at 6 weeks post transplantation.
Funded by Scottish Liver Transplant Unit Endowment Fund
详细描述
Study population:
This prospective observational study will aim to recruit 80-100 consecutive patients admitted for liver transplant assessment to the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh over a 6 month period.
Consent:
Potential participants will be identified by the clinical team involved in the patient's care. Thereafter, potentially suitable participants will be given information about the study both verbally (by a member of the research team) and in writing in the form of the patient information sheet. Potential patients will be given time (up to 24 hours) to consider their participation and discuss this with friends or family. If participants remain interested, written consent will be taken by the principal investigator or a suitably qualified and delegated member of the study site staff.
Study overview:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults over 18 years of age
- •Able to provide written informed consent and able to understand and willing to comply with the requirements of the study
- •Admission for assessment for liver transplantation
排除标准
- •Patients who do not have capacity to consent
- •Patients being assessed for liver transplantation because of acute liver failure
- •Patients who are unwilling or unable to have an MRI scan will be excluded from the ASL-MRI study sub-group
结局指标
主要结局
Relationship between pre-transplant kidney function using novel biomarkers and post-transplant morbidity and mortality.
时间窗: 6 months
(KIM-1, NGAL, Cystatin C)
次要结局
- Relationship between pre-transplant cardiac bioimpedence and post-transplant renal dysfunction(6 months)
- Relationship between pre-transplant plasma KIM-1 and post-transplant renal dysfunction(6 months)
- Relationship between pre-transplant haemodynamic biomarkers and mortality at 1 year(1 year)
- Relationship between pre-transplant kidney perfusion using non-contrast ASL-MRI and pre-transplant renal dysfunction defined by eGFR(7 days)
- Relationship between pre-transplant kidney perfusion using non-contrast ASL-MRI and post-transplant renal dysfunction defined by eGFR(6 months)
- Relationship between retinal nerve fibre layer, choroidal thickness and pre-transplant renal function(7 days)
- Relationship between pre-transplant APWV and post-transplant renal dysfunction(6 months)
- Relationship between pre-transplant urinary protein to creatinine ratio and post-transplant renal dysfunction(6 months)