Effect of Different Timings of Protein Supplementation in Hemodialysis Patients

Protein Supplementation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05953636
• Other study ID #: Timing of protein in HD
• Status: Completed
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Protein Supplementation

Intervention

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 )

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Aexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Agarwal R, Georgianos P. Feeding during dialysis-risks and uncertainties. Nephrol Dial Transplant. 2018 Jun 1;33(6):917-922. doi: 10.1093/ndt/gfx195. — View Citation

Carrero JJ, Nakashima A, Qureshi AR, Lindholm B, Heimburger O, Barany P, Stenvinkel P. Protein-energy wasting modifies the association of ghrelin with inflammation, leptin, and mortality in hemodialysis patients. Kidney Int. 2011 Apr;79(7):749-56. doi: 10.1038/ki.2010.487. Epub 2010 Dec 22. — View Citation

Ikizler TA, Cano NJ, Franch H, Fouque D, Himmelfarb J, Kalantar-Zadeh K, Kuhlmann MK, Stenvinkel P, TerWee P, Teta D, Wang AY, Wanner C; International Society of Renal Nutrition and Metabolism. Prevention and treatment of protein energy wasting in chronic kidney disease patients: a consensus statement by the International Society of Renal Nutrition and Metabolism. Kidney Int. 2013 Dec;84(6):1096-107. doi: 10.1038/ki.2013.147. Epub 2013 May 22. — View Citation

Kalantar-Zadeh K, Ikizler TA, Block G, Avram MM, Kopple JD. Malnutrition-inflammation complex syndrome in dialysis patients: causes and consequences. Am J Kidney Dis. 2003 Nov;42(5):864-81. doi: 10.1016/j.ajkd.2003.07.016. — View Citation

Kistler BM, Benner D, Burrowes JD, Campbell KL, Fouque D, Garibotto G, Kopple JD, Kovesdy CP, Rhee CM, Steiber A, Stenvinkel P, Ter Wee P, Teta D, Wang AYM, Kalantar-Zadeh K. Eating During Hemodialysis Treatment: A Consensus Statement From the International Society of Renal Nutrition and Metabolism. J Ren Nutr. 2018 Jan;28(1):4-12. doi: 10.1053/j.jrn.2017.10.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on nutritional status	assessment of nutritional status change at 6 weeks from baseline using Subjective Global Assessment (SGA)	6 weeks
Primary	effect on blood pressure	systolic and diastolic Blood pressure change at 6 weeks from baseline	6 weeks
Primary	effect on dialysis adequacy	Estimation of Kt/V change at 6 weeks from baseline	6 weeks
Secondary	effect on BMI	BMI assessment change at 6 weeks from baseline	6 weeks
Secondary	effect on serum albumin	• serum albumin change at 6 weeks from baseline	6 weeks