Title: Enabling Research Award: Establishing a clinical phenotype for cachexia in chronic kidney disease.
Funder: Health and Social Care Research and Development Division (HSC R&D) of Public Health Agency, Northern Ireland

Abstract: Background – Cachexia contributes to increased morbidity and premature mortality in persons with chronic illnesses including cancer, cardiac failure and chronic kidney disease. It is a multifactorial syndrome which currently lacks a clear definition in a renal population. Aim – to determine the clinical phenotype of cachexia specific to individuals with CKD. Methods and study population – this is a longitudinal study which will run over two years. All adult haemodialysis patients who attend the Northern Ireland Regional Nephrology Unit (NIRNU), who have a confirmed diagnosis of stage 5 CKD (estimated GFR<15mL/min/1.73m2) will be eligible for inclusion into this study to determine if they experience (and to what degree) the known characteristics associated with cachexia (Table 1). Patients will be monitored for one year (or time to death if <1 year). The NIRNU provides care to approximately 250 stage 5 CKD haemodialysis patients per annum. The recruitment window for this study is approximately 7 months, with a potential patient population of 145. Potential patients will be identified via inpatient wards and outpatient units at NIRNU. Table 1: Characteristics of Cachexia (Mak et al. 2011; Evans et al.2008). Unintentional weight loss ≥5% in 6 months or ≥10% in 12 months (in the absence of documented weights, BMI <20kg/m2) and in the absence of starvation. Plus three of the following five criteria: 1) Decreased muscle strength; 2) Fatigue; 3) Anorexia; 4) Lean tissue depletion; 5) Abnormal biochemistry: increased inflammatory markers [CRP >5mg/L]; anaemia [haemoglobin < 120g/L]; low serum albumin [<32g/L]. Intervention – All adult haemodialysis patients who attend Northern Ireland Regional Nephrology Unit (NIRNU), who have a confirmed diagnosis of stage 5 CKD (estimated GFR<15mL/min/1.73m2) will be eligible for inclusion into this study to determine if they experience (and to what degree) the known characteristics associated with Cachexia (Table 1). All measures will be assessed at baseline and will be repeated every 2 months while in the study. Patients will be asked to complete validated tools to determine fatigue, quality of life and anorexia. We will measure: weight; lean muscle mass (bioelectrical impedance, skinfold thickness, and upper arm circumference); muscle strength (hand held dynamometer); and interrogate routine monthly clinical blood tests for abnormal biochemistry, as detailed in Table 1. Analysis – Analysis will be done on multifactor profiles. We will compare combinations of criteria (Table 1) and their outcomes using multivariate logistic regression and compare time of death with a parallel cohort of stage 5 CKD patients receiving haemodialysis without weight loss. Expected outcome – From this research we will identify the characteristics of cachexia in a stage 5 CKD haemodialysis population. This predictive profile will require prospective validation, which will be done through the NETS study. The findings from this study will be used as pilot clinical data to inform an


Research activity codes: 2.4 SURVEILLANCE AND DISTRIBUTION
Health categories: RENAL AND UROGENITAL