Investigating Nutrition and Functional Outcome in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of Refeeding syndrome
研究概览
简要总结
This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.
详细描述
The investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. At least 100 consecutive patients requiring surgery, who are admitted to any surgical ICU at the University Hospital RWTH Aachen will be recruited. Nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from ICU-admission until hospital discharge. Patient outcomes, such as ICU- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. To assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured.
This observational trial aims to assess the current standard of nutritional practice in the ICU, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. This study also aims to compare the outcome of the predefined subgroups of critically ill patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Adult patients (≥ 18 years)
- •Patients admitted to a surgical ICU requiring surgical Intervention
- •Patients requiring sedation and invasive ventilation for ≥ 48 hours
- •Patients with an expected ICU-length of stay ≥ 72 hours
排除标准
- •Pregnant or lactating patients
- •Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission
- •Patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before ICU admission
- •Patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders)
- •Death expected within 96 hours after admission due to severity of disease
- •Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)
结局指标
主要结局
Incidence of Refeeding syndrome
时间窗: discharge from intensive care unit, an average of 30 days
Chart review
Nutritional Status - nutritional screening
时间窗: intensive care unit (ICU) admission, up to 1 week
Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
Timing of nutrition
时间窗: until discharge from intensive care unit, an average of 30 days
Chart Review- start and stop times
Change in Physical function - Manual Muscle Testing (MMT)
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
MMT
Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
时间窗: Hospital discharge, day 30 after study inclusion, up to 3 months
IADL (score 0-8; the higher the more independent)
Change in Fat mass
时间窗: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Thigh and abdominal fat (ultrasound)
Nutritional status - basic demographics
时间窗: at Study inclusion
Chart review
Nutritional Status - nutritional risk in the critically ill (NUTRIC)
时间窗: ICU admission, up to 1 week
NUTRIC score (Score 0-10; if interleucin-6 (IL6) available 0-5=low malnutrition risk; if IL6 not available 0-4= at low malnutrition risk
Nutritional Status - Waist and mid-arm circumferences
时间窗: Study inclusion, up to 1 week
Waist and mid-arm circumferences
Incidence of complications related to the route of administration
时间窗: discharge from intensive care unit, an average of 30 days
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
Differences of dosage of nutrition
时间窗: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by nutrition used
Timing of nutrition - reason for discontinuation
时间窗: at discharge from intensive care unit, an average of 30 days
Chart review
Incidence of Gastrointestinal symptoms
时间窗: discharge from intensive care unit, an average of 30 days
Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
Differences in route of administration of nutrition
时间窗: discharge from intensive care unit, an average of 30 days
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
Incidence Blood work irregularities
时间窗: discharge from intensive care unit, an average of 30 days
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
Nutrition adequacy
时间窗: discharge from intensive care unit, an average of 30 days
Rates of energy and protein received in comparison to nutritional targets Chart review
Change in Muscle mass - Mid-arm circumference (MAC)
时间窗: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
MAC
Change in Muscle mass - Quadriceps thickness
时间窗: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Change in Physical function - Short Physical Performance Battery
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
Short Physical Performance Battery (SPPB) (Score: 0-12; 0=worst performance and 12=best performance)
Change in Muscle mass - Quadriceps cross sectional area
时间窗: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Change in Muscle strength - Handgrip strength
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
Change in Physical function - Functional Status Score for the ICU
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
Functional Status Score for Intensive Care Unit (FSS-ICU) (Score 0-35; the higher the score, the better physical functioning)
Change in Muscle strength - Quadriceps strength
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
Change in Physical function - 6-Minute Walk Test
时间窗: discharge from intensive care unit and hospital discharge, up to 3 months
6-minute walking distance
Change in Physical function - Clinical Frailty Score (CFS)
时间窗: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
CFS (score 1-9; 1= Very fit and 9=terminally ill)
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
时间窗: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
MMSE (Score 0-30; 30= no dementia and \<9= severe dementia)
Quality of life - Short Form 36 (SF-36)
时间窗: day 30 after study inclusion
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
Change in Neuro-psychological function - Becks Depression Inventory (BDI)
时间窗: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
BDI (Score 0-63; 0= no depression and 63= severe depression)
Quality of life - Living location
时间窗: day 30 after study inclusion
Rates of patients being discharged to nursing home, rehabilitation, home care etc. Discharge location used as surrogate for physical fitness after hospital discharge.
Change in Physical function - Katz Activities of Daily Living (ADL)
时间窗: Hospital discharge, day 30 after study inclusion, up to 3 months
ADL (Score: 0-100; the higher the more independent)
次要结局
- Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)(up to discharge from intensive care unit, an average of 30 days)
- Acute organ dysfunction - Richmond Agitation Scale(up to discharge from intensive care unit, an average of 30 days)
- Mortality Rate(up to 30 days after study inclusion)
- Length of stay - Hospital length of stay(Hospital discharge, an average of 60 days)
- Readmission - ICU readmission rate(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Acute organ dysfunction - hemodynamic parameters(up to discharge from intensive care unit, an average of 30 days)
- Persistent Organ Dysfunction - Incidence of renal replacement therapy(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Complications - Rate of hemorrhage(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Length of stay - intensive care unit length of stay(discharge from intensive care unit, an average of 30 days)
- Readmission - Hospital readmission rate(up to 30 days after study inclusion, up to 3 months)
- Acute organ dysfunction - sedation(up to discharge from intensive care unit, an average of 30 days)
- Complications - Rate of cardiovascular events(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Acute organ dysfunction - incidence of ventilation(up to discharge from intensive care unit, an average of 30 days)
- Acute organ dysfunction - duration of ventilation(up to discharge from intensive care unit, an average of 30 days)
- Complications - Rate of surgical reevaluation(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Complications - Rate of sepsis(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)(up to discharge from intensive care unit, an average of 30 days)
- Persistent Organ Dysfunction - Incidence of mechanical ventilation(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Persistent Organ Dysfunction - Incidence of hemodynamic parameters(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Complications - Rate of thromboembolic events(Hospital discharge, day 30 after study inclusion, up to 3 months)
- Complications - Rate of infection(Hospital discharge, day 30 after study inclusion, up to 3 months)
研究者
Christian Stoppe
Principal Investigator
University Hospital, Aachen