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临床试验/NCT07032441
NCT07032441尚未招募不适用

Association Between Sleep Deprivation and Malnutrition in Intensive Care Unit Patients: A Prospective Observational Cohort Study

Shanghai Zhongshan Hospital0 个研究点目标入组 150 人开始时间: 2025年8月1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
150
主要终点
Prevalence of malnutrition

研究概览

简要总结

Study Design This study is a prospective cohort design conducted at Zhongshan Hospital affiliated with Fudan University. It will involve systematic assessments of sleep quality, nutritional status, and associated clinical outcomes in adult ICU patients over a defined observation period.

Sample Size: An estimated 150 adult patients (≥18 years) will be recruited from the ICU.

Assessments 1. Sleep Quality Assessment:

  1. Polysomnography (PSG): Sleep quality and duration will be quantified using PSG, which records brain waves, blood oxygen levels, heart rate, and breathing, as well as eye and leg movements. This will provide a comprehensive picture of sleep architecture and disturbances.

  2. Sleep Quality Index: In addition to PSG data, the Pittsburgh Sleep Quality Index (PSQI) will be administered to assess subjective sleep quality, sleep latency, duration, habitual sleep efficiency, sleep disturbances, and daytime dysfunction.

  3. Nutritional Status Evaluation:

  4. Nutritional Risk Screening Tools: The Nutritional Risk Screening (NRS-2002) and the Malnutrition Universal Screening Tool (MUST) will be applied to assess nutritional risk and identify malnutrition.

  5. Biochemical Assessment: Blood samples will be collected to measure biochemical indicators such as serum albumin, transferrin, prealbumin, and other relevant markers of nutritional status.

  6. Anthropometric Measurements: Body mass index (BMI) and muscle mass assessments will be conducted using bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DEXA) to quantify body composition.

  7. Physiological Monitoring:

  8. Continuous monitoring of vital signs, including heart rate, blood pressure, and respiratory rate, will be performed.

  9. Assessment of immune function through laboratory tests, including white blood cell count and levels of inflammatory markers (C-reactive protein).

  10. Complications Tracking:

  11. Data on complications such as infections, delayed wound healing, and respiratory failure will be systematically recorded throughout the ICU stay.

This study aims to elucidate the complex interplay between sleep deprivation and malnutrition in ICU patients. By identifying key associations and influencing factors, we hope to inform targeted clinical interventions that can improve patient care, recovery, and quality of life. The findings will serve as a foundation for future research exploring the intricate relationships between sleep and nutritional status in critical care settings.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult ICU patients (≥18 years)
  • •Expected length of stay ≥5 days
  • •No severe liver or kidney failure (to avoid confounding in nutritional metabolism)

排除标准

  • •Pre-existing malnutrition upon admission (e.g., BMI <18.5 or weight loss >10% within 6 months)
  • •Neuromuscular diseases affecting metabolic assessment

结局指标

主要结局

Prevalence of malnutrition

时间窗: From enrollment to the end of treatment at 8 weeks

NRS-2002

Changes in physiological indicator

时间窗: From enrollment to the end of treatment at 8 weeks

Muscle mass

次要结局

  • The length of stay (LOS) in ICU(From enrollment to the end of treatment at 8 weeks)
  • Incidence of complications(From enrollment to the end of treatment at 8 weeks)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

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