Protein Supplementation During Dialysis (PROSED)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nottingham

About this trial

When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.

Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years (no upper age limit)

Patients receiving maintenance dialysis for ≥ three months

Ability to provide informed consent

Disqualifiers

Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.

Anticipated change of dialysis modality within the period of sample collection

Renal 7-point Subjective Global Assessment (SGA) scores of 1-2

Global Leadership Initiative Malnutrition (GLIM) Stage 2

Trial design

Design model

Parallel

Treatments tested in this trial

  • High Protein Diet/Modular protein supplements will be used

    Dietary supplement

    High Protein Diet/Supplements 1.4g/kg/body weight/day

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Standard Protein ArmNo intervention 0 interventions
Group B: High Protein ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.

Purpose To measure the impact of different amounts of protein intake (protein in the diet) on clinical outcomes (including unplanned hospital admissions) in patients receiving the different dialysis modalities (ICHD, HHD, NHD and PD). The investigators hypothesis is that a modality-specific and high-protein supplementation regimen reduces unplanned hospitalisation rate in patients receiving dialysis (ICHD, PD, HD, NHD) compared with those without supplementation.

Time frame
2 years

Secondary outcomes

1

To assess association between protein intake and patients related outcomes measures.

To assess the correlation between protein intake and: * the rate of mortality * the incidence of cardiovascular events * % of patients of specific medications (such as erythropoietin, antibiotics, as well as other medications) * infection rates * nutritional status , including body composition (measured via bioimpedence in kg of fat mass and kg fat free mass, calf circumference in cm), functional markers of muscle mass (measured via hand grip strength in kg and hand grip index) * quality of life will be measure via a scales SF-36 and EuroQoL-5D The following assessments will be performed using the following measurements: Chronic Kidney Disease physical activity questionnaire Karnofsky score Subjective Global Assessment Global Leadership Initiative malnutrition tool Clinical Frailty score Malnutrition Inflammation score Sarcopenia -F tool

Time frame
2 years

Other outcomes

Sponsors and contacts

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University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

University Hospitals of Derby and Burton NHS Foundation Trust

Collaborator

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