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临床试验/NCT05997745
NCT05997745尚未招募不适用

Effects of Early Enteral Nutrition With a Locally Produced Protein-energy Ration Versus a Marketed Nutritional Solution in Patients Operated on for Acute Generalized Peritonitis

Université Evangélique enAfrique0 个研究点目标入组 76 人开始时间: 2023年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
76
主要终点
Tolerability of feeding

研究概览

简要总结

Hospitals in South Kivu always have problems supplying artificial enteral nutritional products because of their high cost and low availability in our areas. While the Province has cereals, knowing their nutritional composition would enable the formulation of a nutritional product based on local protein-energy products. Hence the questions below: Can a local cereal-based protein-energy ration be used instead of a costly imported artificial nutritional solution to improve the nutritional status of patients operated on for PAG? What is the tolerance of this early enteral nutrition on the healing and functional recovery of patients compared with an artificial nutritional solution? To answer these questions, a randomized clinical trial has been designed with the following objectives:

  • To formulate an enteral diet using cereals available in our environment with a protein-calorie composition superimposable on the artificial enteral ration,
  • Evaluate the tolerance and advantages of early enteral nutrition with a locally manufactured protein-caloric ration vs. a commercially available artificial nutritional solution in patients undergoing surgery for PAG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • patient operated for peritonitis with intestinal suture during treatment
  • have a q-SOFA score of 1 to 2
  • surgeon's agreement to enteral feeding
  • at risk of malnutrition (BMC)

排除标准

  • q SOFA score > 2
  • patients with tare (diabetes, HIV, renal failure)

结局指标

主要结局

Tolerability of feeding

时间窗: 10 days after surgery

We will screen complications after feeding

次要结局

  • nutritional surveillance(2 days after, 5 days after, 10 days after feeding)

研究者

发起方
Université Evangélique enAfrique
申办方类型
Other
责任方
Sponsor

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