NCT05953636

Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

The Effect of Different Timings of Protein Supplementation on Variable Outcomes in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this work is to study the effect of different timings of protein supplementation on variable outcomes in hemodialysis patients.

Detailed description

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.

Conditions

• Protein Supplementation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session)	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 )

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-04-01
• Completion: 2024-05-01
• First posted: 2023-07-20
• Last updated: 2024-07-01

Locations

1 site across 1 country: Egypt