Faculty of Medicine, Aexandria University
Alexandria, 21526, Egypt
NCT Number: NCT05953636
The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Alexandria, 21526, Egypt
Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD. PEW, showing a high prevalence (up to 50-75%) in patients with CKD stages 4-5, is closely associated with both increased morbidity/mortality risk and worsens quality of life.
Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.
It is common for nephrologists to prescribe oral nutritional supplements (ONS), but the compliance to these at prescribed doses is relatively low. While directly administering ONS during hemodialysis (HD) ensures compliance and has been shown to improve nutritional status in these patients, the risks of intradialytic hypotension, inadequate dialysis, hygiene issues, and staff burden remain major deterrents for caregivers from formulating policies with regard to intradialytic meals.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) given in group A (predialytic: 1 hour before the start of the session), in group B (intradialytic: 2 hours after the start of the session ), in group C (interdialytic: in non-dialysis days )
Time frame: 6 weeks
assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)
Time frame: 6 weeks
systolic and diastolic Blood pressure change at 6 weeks from baseline
Time frame: 6 weeks
Estimation of Kt/V change at 6 weeks from baseline
Time frame: 6 weeks
BMI assessment change at 6 weeks from baseline
Time frame: 6 weeks
Alexandria University
Other
The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients
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