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Clinical Trials/NCT05953636
NCT05953636CompletedNot Applicable

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

Alexandria University2 sites in 1 country120 target enrollmentStarted: November 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
effect on dialysis adequacy

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult hemodialysis patients (≥18 years of age).
  • Received dialysis for at least 6 months prior to study screening.
  • Receive hemodialysis at least 3 times per week .

Exclusion Criteria

  • Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study .
  • Participants with an allergy to any ingredients in the nutritional supplements.
  • Significant edema and fluid overload.
  • Hepatic patients.

Outcomes

Primary Outcomes

effect on dialysis adequacy

Time Frame: 6 weeks

Estimation of Kt/V change at 6 weeks from baseline

effect on nutritional status

Time Frame: 6 weeks

assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)

effect on blood pressure

Time Frame: 6 weeks

systolic and diastolic Blood pressure change at 6 weeks from baseline

Secondary Outcomes

  • effect on serum albumin(6 weeks)
  • effect on BMI(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Lecturer

Alexandria University

Study Sites (2)

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