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临床试验/NCT05533645
NCT05533645招募中不适用

Development and Validation of a Food Frequency Questionnaire to Assess Sodium Intake in Hospitalized Patients or in Medical Consultation

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2023年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
99
试验地点
1
主要终点
Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values

研究概览

简要总结

EvalSel can precisely assess the salt intake of hospitalized patients in nephrology and cardiology or in medical consultation. It can determine salt consumption to the nearest gram.

The objectives of this food frequency questionnaire are to arrive at a precise dietary diagnosis and to quickly identify the dietary errors made by the patients.

EvalSel is useful for doctors to quickly obtain an assessment of the salt consumption of their patients, so they can refer them to dietitians if necessary. It can be used on the day of admission to hospital or during medical follow-ups to know the evolution of their consumption over the long term and improve their care.

研究设计

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

  • Patients with high blood pressure, CKD stages 4-5 and patients free from any diseases
  • Patients over 18 years old
  • Patients in nephrology and cardiology consultation or recruited by CIC
  • Patients with health insurance
  • Patients willing to follow the full study

排除标准

  • Loss of salt by vomiting, diarrhea or sweating (intense sport or intense fever 3 days before urine collection) which can cause a decreasing natriuresis
  • Modification of the therapeutic management of patients during the study period
  • Taking certain drugs like effervescent drugs, Gaviscon and Tolvaptan during the day of urine collection, as well as diuretics (unless they are taken long-term and the diuresis is stable) which can cause an increasing natriuresis
  • Pregnant or breastfeeding women
  • Patients protected by law

结局指标

主要结局

Intra-class correlation coefficient between the quantitative measurement of sodium consumption and the 24-hour natriuresis measurement and verification of the 24-hour creatininuria values

时间窗: through study completion an average of 18 months

Intra-class correlation coefficient between the quantitative measurement of sodium consumption by the EvalSel questionnaire and the 24-hour natriuresis measurement (amount of sodium in 24-hour urine) and verification of the 24-hour creatininuria values (amount of creatinine in 24-hour urine) to confirm that the urine collection was performed correctly.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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