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临床试验/NCT05433831
NCT05433831Unknown不适用

Feasibility of Application of Nutritional Ultrasound in the Diagnosis and Follow-up of Patients With Nutritional Risk at Hospital Discharge: Study on Body Composition and Function: DRECO Study

K Access Health Projects25 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
25
主要终点
Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.

研究概览

简要总结

Disease-related malnutrition (DRM) can occur when there is a deficient supply of energy, protein and/or other nutrients, depending on the nutritional needs of each individual at different times of their life cycle or health or disease circumstances. This deficiency induces effects on body composition and tissue and organ function and results in clinical consequences: increased morbidity and mortality associated with different disease processes.

There are techniques for nutritional assessment using assessment tools aimed at morphofunctional diagnosis of malnutrition, in addition to the classical nutritional parameters, such as weight loss, BMI, folds, circumferences, albumin, lymphocytes, cholesterol and intake. New advanced parameters are being incorporated into clinical nutrition and their incorporation into clinical practice is of increasing interest, such as measures derived from bioelectrical impedance (BIA) and phase angle (PhA), dynamometry, functional tests, CRP/prealbumin ratio and muscle ultrasound.

In 2019, the GLIM criteria were published, providing a different vision of how to assess the malnourished patient. Phenotypic criteria include reduction in muscle mass (measured using validated techniques to measure body composition).

The objective of the study is to highlight nutritional ultrasound for measuring muscle and functional status in order to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in this type of patients.

详细描述

Prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to hospital who in the first week of admission have moderate or high risk of malnutrition according to the MUST and SARC-F screening test using R-MAPP. Appendix
  • Patient aged 18 to 85 years.
  • Patient who agrees to participate in the study and signs the informed consent.

排除标准

  • Hepatic impairment (AST/ALT 3 x upper limit of normal)
  • Chronic kidney failure (GFR <45 mL/min)
  • Patient with previous ICU stay during the study admission.
  • Cancer patients on palliative treatment or ECOG (Eastern Cooperative Oncology Group) ≥
  • Orthopaedic disease that does not allow adequate walking
  • Patients with known dementia or others not related to a significant neurological or psychiatric disorder, or any other psychological condition that may interfere with the conduct of the study.
  • Patients with eating disorders
  • Life expectancy of less than 6 months.
  • Patients unable to adequately complete the clinical laboratory assessments required for the study protocol.

结局指标

主要结局

Nutritional ultrasound measurements: ultrasound with 4-10 cm linear probe.

时间窗: Patients will be followed over a period of 6 consecutive months

* Abdominal ultrasound: total, superficial and pre-peritoneal adipose tissue (measured in centimetres). * Muscle ultrasound: Area, circumference, axes and adipose tissue (measured in centimetres)

次要结局

  • Subjective Global Assessment (SGA)(Patients will be followed over a period of 6 consecutive months)
  • Anthropometric data:(Patients will be followed over a period of 6 consecutive months)
  • Blood biochemistry data (at baseline visit, at 3 and 6 months):(Patients will be followed over a period of 6 consecutive months)
  • Functional parameters:(Patients will be followed over a period of 6 consecutive months)
  • Sociodemographic data:(Patients will be followed over a period of 6 consecutive months)
  • Bioelectrical impedance data (model (50 kHz):(Patients will be followed over a period of 6 consecutive months)
  • Current patient status:(Patients will be followed over a period of 6 consecutive months)
  • Adherence.(Patients will be followed over a period of 6 consecutive months)

研究者

发起方
K Access Health Projects
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. José Manuel García Almeida

Clinical Management Unit of Endocrinology and Nutrition

Hospital Universitario Virgen de la Victoria

研究点 (25)

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