Renal failure Urological and Genital Diseases
Conditions
Interventions
This is a feasibility study that will be conducted in the Royal Derby Hospital renal dialysis unit and Lichfield dialysis centre.
Participants will be randomly assigned (similar to picking names from
Sponsors
University Hospitals of Derby and Burton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years (no upper age limit) 2. Dialysis regime of >=3 haemodialysis sessions/week for >=3 hours using biocompatible dialysers 3. Able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Treatment with immunosuppressant drugs 2. Body mass index (BMI) >35 kg/m² 3. Pregnancy, breastfeeding or intending pregnancy 4. Expected survival 5.3 mmol/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of conducting a randomised controlled trial of immuno-nutrition vs standard nutritional supplementation. Feasibility outcomes will include the following: 1. Screening: the number of patients who are screened will be provided as a total, measured during recruitment before baseline assessment 2. Eligibility rate: defined as the proportion of eligible patients out of the total number of patients screened, measured during recruitment before baseline assessment 3. Approach rate: defined as the proportion of patients approached out of the total number of eligible patients, measured during recruitment before baseline assessment 4. Consent rate: defined as the proportion of patients who provide informed consent out of the total number of patients approached, measured during recruitment before baseline assessment 5. Refusal rate: defined as the proportion of patients who refuse to take part in the study out of the total number of patients approached, measured during recruitment before baseline assessment 6. Randomisation rate: defined as the proportion of patients who get randomised to take part in the study out of the total number of patients approached, measured during recruitment before baseline assessment 7. Completion rates: completion of each outcome assessment will be calculated at each appropriate study visit. This is defined as the number of participants completing the assessment out of the participants who are still expected to complete the assessment at that visit (i.e., those who remain in the trial and have not withdrawn consent for follow-up assessments). Measured at baseline, 12, 18 and 24 weeks. 8. Adherence rate: calculated for each participant as the proportion of daily doses taken out each month throughout 24 weeks and overall. Adherence rate will be reported as the proportion of participants who meet the pre-specified adherence threshold of 75%. Measured at 4, 8, 12, 16, 20 and 24 weeks 9. Acceptability of both nutritional supplements wil | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Muscle strength will be assessed with handgrip strength at baseline, 12, 18 and 24 weeks 2. Body composition will be assessed with bioelectrical impedance analysis at baseline, 12, 18 and 24 weeks 3. Physical performance will be assessed with the Short Physical Performance Battery at baseline, 12, 18 and 24 weeks 4. Prevalence of sarcopenia and severe sarcopenia will be reported according to the definition from the European Working Group on Sarcopenia in Older People at baseline, 12, 18 and 24 weeks 5. Dietary intake will be assessed with 3-day food diaries at baseline, 12, 18 and 24 weeks 6. Routine blood samples will be taken at baseline, 12, 18 and 24 weeks and be transferred to the local NHS laboratory for routine biochemistry and haematology testing, including haemoglobin, urea, creatinine, potassium, phosphate, calcium, albumin, total protein and parathyroid hormone 7. Systemic inflammation will be assessed with plasma levels of pro-inflammatory cytokines (interleukin [IL]-6 and IL-8) analysed via enzyme-linked immunosorbent assays at baseline, 12, 18 and 24 weeks 8. Health-related quality of life will be assessed using the Kidney Disease Quality of Life 36-item short-form survey at baseline, 12, 18 and 24 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactKirsty;Chris Brown;Stait
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Outcome results
None listed