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临床试验/NCT05568914
NCT05568914招募中不适用

Intra Dialytic Parenteral Nutrition During Intermittent Hemodialysis Can Close the Nutritional Gap Identified by Indirect Calorimetry: a Pilot and Feasibility Study

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
2
主要终点
Caloric adequacy

研究概览

简要总结

Renal failure is a relevant condition as the incidence of patients treated with intermittent dialysis continues to grow each year. One of the strongest predictors of mortality in these patients is Protein-Energy Wasting (PEW). Optimal nutritional support, combined with physical exercise may be able to improve the physical condition objectified as muscle wasting and weakness. Correct nutritional support must aim to supplement the correct combination of protein and caloric needs. Although no other way exist than predicting formula to assess protein need, predicting formula don't seem to capture the individual caloric need of the patients. The gold standard to assess caloric need by measuring Resting Energy Expenditure (REE) is indirect calorimetry. Even when caloric and protein targets are defined, intake remains a challenge because of intake restriction in dietary patterns. This is why intradialytic parenteral nutrition (IDPN) can play an crucial role for closing the nutritional gap. Whether IDPN guided by indirect calorimetric measurements of metabolism can close the gap when oral intake fails, remains an unanswered question.

详细描述

Renal failure is a relevant condition as the incidence of patients treated with renal replacement therapy and specifically intermittent dialysis, continues to grow each year. In 2021 up to 4845 patients required intermittent dialysis in Flanders, Belgium. Weight loss and homeostatic disturbances of energy and protein balances are often present in Chronic Kidney disease (CKD) and end-stage renal disease (ESRD).The international society of renal nutrition and metabolism defines Protein-Energy Wasting (PEW) as the state of nutritional and metabolic disorders in patients with CKD and ESRD, characterized by simultaneous loss of systemic body protein and energy stores. PEW is one of the strongest predictors of mortality in CKD patients. Up tot 54% of adults undergoing chronic intermittent haemodialysis (IHD) suffer from PEW due to a combination of the disease and therapy. Adequate nutritional therapy can reverse the negative impact of PEW. Optimal nutritional support, next to physical exercise may be able to improve the physical condition objectified as muscle wasting and weakness. Correct nutritional support must aim to supplement the correct combination of protein and caloric after assessing the needs and intake of different nutrients. Although no other way exist than predicting formula to assess protein need, predicting formula don't seem to capture the individual caloric need of the patients. The gold standard to assess caloric need by measuring Resting Energy Expenditure (REE) is indirect calorimetry. This technique measures the individual VCO2 and VO2 and after integrating it into the Weir equation it calculates REE. Even when caloric and protein target are defined, intake remains a challenge because of intake restriction in dietary patterns. This is why intradialytic parenteral nutrition (IDPN) can play an crucial role for closing the nutritional gap. In clinical practice, in 38% of dialysis patients, IDPN is used. The most common IDPN were triple phase bags. Whether IDPN guided by indirect calorimetric measurements of metabolism can close the gap when oral intake fails, remains an unanswered question.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

入选标准

  • Patient on intermittent hemodialysis
  • Protein-Energy Wasting defined as 5% within 3 months or 10% within 6 months (not due to water loss, established at the discretion of the treating physician)

排除标准

  • Pregnancy
  • Contra-indications for the use of indirect calorimetry as stated by the AARC (oxygen therapy for COPD,...)
  • Metabolic diseases

结局指标

主要结局

Caloric adequacy

时间窗: Pre-dialysis

caloric intake (kcal/day) and caloric need (kcal/day) (see secondary outcomes) will be combined to report caloric adequacy according to this equation: \[sum of percentage of caloric intake/caloric need\]/total of evaluable nutrition days (%)

次要结局

  • Protein adequacy(Pre-dialysis)
  • Fat Free Mass (FFM)(20-30 minutes after dialysis)
  • Mean caloric intake(pre-dialysis)
  • Fat Mass (FM)(20-30 minutes after dialysis)
  • Caloric need(pre-dialysis)
  • Compatibility between the caloric gap and PN ready to use formulae on the market(through study completion or one year, whichever is sooner)
  • Phase angle(20-30 minutes after dialysis)
  • Body weight(before and after hemodialysis)
  • Barriers for patients for use of IDPN(pre-dialysis)
  • Mean protein intake(pre-dialysis)
  • Barriers for dialysis nurses and nephrologists for use of IDPN(throughout the duration of the trial)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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