Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline level of hemoglobin at 14 days after surgical operation
研究概览
简要总结
Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.
详细描述
Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •caucasian
- •arthroplasty intervention program with hip prosthesis placement
- •signature and acceptance of informed consent to collaborate in all the procedures necessary for the study
排除标准
- •heart failure stage III-IV
- •renal failure stage III-IV
- •actual cancer
- •past neurological disorders (including, but not limited to cerebral ischemia, cerebral haemorrhages, brain tumors, endocranial aneurysms)
- •neurodegenerative disorders (including, but not limited to Alzheimer's dementia, fronto-temporal dementia)
- •actual major psychopharmacological therapies
- •pregnancy certified by self-declaration
- •inability to adhere to the rehabilitation protocol or to carry out the controls
- •non-acceptance of informed consent
- •revision interventions
- •previously established and documented sleep disorders
- •shift or part-time worker
结局指标
主要结局
Change from baseline level of hemoglobin at 14 days after surgical operation
时间窗: Before the surgical operation, after 3 days, after 14 days.
One of the main decision-making factors that guide the clinician to discharge the patient is the hemoglobin level. The association between preoperative hemoglobin and hemoglobin at discharge was already observed in past orthopedic cohorts, with a loss of 3.3 g/dl being considered clinically relevant. Patients with a better nutritional status may have a reduced fall in hemoglobin after the surgical operation.
次要结局
- Change from baseline of weight 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline level of vitamin D at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of hand-grip strength at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline level of total lymphocyte count at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline level of iron at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of POMA at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline level of pre-albumin at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of calf circumference 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of % of fat mass at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of FIM test at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)
- Change from baseline of 10 meter walking test at 14 days after surgical operation(Before the surgical operation, after 3 days, after 14 days.)