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临床试验/NCT05953636
NCT05953636已完成不适用

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

Alexandria University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
effect on dialysis adequacy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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 .

排除标准

  • •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.

研究组 & 干预措施

pre-dialytic

Other

40 patients will receive oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 8 weeks 1 hour before the start of the session (pre-dialytic).

干预措施: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) (Dietary Supplement)

intra-dialytic

Other

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks 2 hours after the start of the session (intra-dialytic).

干预措施: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) (Dietary Supplement)

inter-dialytic

Other

40 patients will receive oral protein nutritional supplement (ONS) for 8 weeks in non-dialysis days (inter-dialytic).

干预措施: oral protein nutritional supplement (ONS) (Fresubin protein powder 25mg/5scoops per hemodialysis session) (Dietary Supplement)

结局指标

主要结局

effect on dialysis adequacy

时间窗: 6 weeks

Estimation of Kt/V change at 6 weeks from baseline

effect on nutritional status

时间窗: 6 weeks

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

effect on blood pressure

时间窗: 6 weeks

systolic and diastolic Blood pressure change at 6 weeks from baseline

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

Lecturer

Alexandria University

研究点 (1)

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