Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)
2022年5月25日 更新者：Christian Stoppe、RWTH Aachen University
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.
研究概览
地位
完全的
详细说明
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.
研究类型
观察性的
注册 (实际的)
100
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
NRW
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Aachen、NRW、德国、52074
- RWTH Aachen University Hospital
-
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
This is a clinical trial, which will include critically ill patients after informed consent.
Patients who admitted to a surgical ICU following surgery or requiring surgery can be screened and included by our team.
The general eligibility criteria are listed above.
We will recruit patients, who can be classified as one of the following groups: a) neurosurgical Patients, b) elderly patients, c) obese patients, d) cardiac surgery patients and e) abdominal surgery patients
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Neurosurgical patients
Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups:
|
Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
|
|
Elderly patients
Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years
|
Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
|
|
Obese patients
BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2
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Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
|
|
Cardiac surgery patients
Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups:
|
Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
|
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Abdominal surgical patients
Admission to the abdominal surgery ICU after abdominal surgery
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Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Nutritional status - basic demographics
大体时间：at Study inclusion
|
Chart review
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at Study inclusion
|
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Nutritional Status - nutritional screening
大体时间：intensive care unit (ICU) admission, up to 1 week
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Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
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intensive care unit (ICU) admission, up to 1 week
|
|
Nutritional Status - nutritional risk in the critically ill (NUTRIC)
大体时间：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
|
ICU admission, up to 1 week
|
|
Nutritional Status - Waist and mid-arm circumferences
大体时间：Study inclusion, up to 1 week
|
Waist and mid-arm circumferences
|
Study inclusion, up to 1 week
|
|
Differences of dosage of nutrition
大体时间：until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by infusion rates
|
until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
大体时间：until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by cumulative count of macronutrients
|
until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
大体时间：until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by nutrition used
|
until discharge from intensive care unit, an average of 30 days
|
|
Timing of nutrition
大体时间：until discharge from intensive care unit, an average of 30 days
|
Chart Review- start and stop times
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until discharge from intensive care unit, an average of 30 days
|
|
Timing of nutrition - reason for discontinuation
大体时间：at discharge from intensive care unit, an average of 30 days
|
Chart review
|
at discharge from intensive care unit, an average of 30 days
|
|
Differences in route of administration of nutrition
大体时间：discharge from intensive care unit, an average of 30 days
|
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of Gastrointestinal symptoms
大体时间：discharge from intensive care unit, an average of 30 days
|
Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence Blood work irregularities
大体时间：discharge from intensive care unit, an average of 30 days
|
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
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discharge from intensive care unit, an average of 30 days
|
|
Incidence of Refeeding syndrome
大体时间：discharge from intensive care unit, an average of 30 days
|
Chart review
|
discharge from intensive care unit, an average of 30 days
|
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Incidence of complications related to the route of administration
大体时间：discharge from intensive care unit, an average of 30 days
|
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
|
discharge from intensive care unit, an average of 30 days
|
|
Nutrition adequacy
大体时间：discharge from intensive care unit, an average of 30 days
|
Rates of energy and protein received in comparison to nutritional targets Chart review
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discharge from intensive care unit, an average of 30 days
|
|
Change in Muscle mass - Mid-arm circumference (MAC)
大体时间：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
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MAC
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Muscle mass - Quadriceps thickness
大体时间：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
ultrasound
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Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Muscle mass - Quadriceps cross sectional area
大体时间：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
ultrasound
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Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle strength - Handgrip strength
大体时间：discharge from intensive care unit and hospital discharge, up to 3 months
|
Dynamometry
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle strength - Quadriceps strength
大体时间：discharge from intensive care unit and hospital discharge, up to 3 months
|
Dynamometry
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Functional Status Score for the ICU
大体时间：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)
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discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Short Physical Performance Battery
大体时间：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)
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discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Physical function - 6-Minute Walk Test
大体时间：discharge from intensive care unit and hospital discharge, up to 3 months
|
6-minute walking distance
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Manual Muscle Testing (MMT)
大体时间：discharge from intensive care unit and hospital discharge, up to 3 months
|
MMT
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Katz Activities of Daily Living (ADL)
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
ADL (Score: 0-100; the higher the more independent)
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Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
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IADL (score 0-8; the higher the more independent)
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Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Change in Physical function - Clinical Frailty Score (CFS)
大体时间：Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
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CFS (score 1-9; 1= Very fit and 9=terminally ill)
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Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Change in Fat mass
大体时间：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
Thigh and abdominal fat (ultrasound)
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
大体时间：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)
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discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Change in Neuro-psychological function - Becks Depression Inventory (BDI)
大体时间：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)
|
discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Quality of life - Short Form 36 (SF-36)
大体时间：day 30 after study inclusion
|
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
|
day 30 after study inclusion
|
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Quality of life - Living location
大体时间：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.
|
day 30 after study inclusion
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mortality Rate
大体时间：up to 30 days after study inclusion
|
Mortality
|
up to 30 days after study inclusion
|
|
Length of stay - intensive care unit length of stay
大体时间：discharge from intensive care unit, an average of 30 days
|
ICU length of stay
|
discharge from intensive care unit, an average of 30 days
|
|
Length of stay - Hospital length of stay
大体时间：Hospital discharge, an average of 60 days
|
Hospital length of stay
|
Hospital discharge, an average of 60 days
|
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Readmission - ICU readmission rate
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
ICU readmission rate
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Readmission - Hospital readmission rate
大体时间：up to 30 days after study inclusion, up to 3 months
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Hospital readmission rate
|
up to 30 days after study inclusion, up to 3 months
|
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Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
大体时间：up to discharge from intensive care unit, an average of 30 days
|
daily records (score 0-24; 0=normal function and 24= massively impaired function)
|
up to discharge from intensive care unit, an average of 30 days
|
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Acute organ dysfunction - hemodynamic parameters
大体时间：up to discharge from intensive care unit, an average of 30 days
|
blood pressure in mmHg
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - hemodynamic parameters
大体时间：up to discharge from intensive care unit, an average of 30 days
|
vasopressors, cumulative dosage in ml/d
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - hemodynamic parameters
大体时间：up to discharge from intensive care unit, an average of 30 days
|
heart rate bpm
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - incidence of ventilation
大体时间：up to discharge from intensive care unit, an average of 30 days
|
mode of ventilation
|
up to discharge from intensive care unit, an average of 30 days
|
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Acute organ dysfunction - duration of ventilation
大体时间：up to discharge from intensive care unit, an average of 30 days
|
hours of ventilation
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - sedation
大体时间：up to discharge from intensive care unit, an average of 30 days
|
duration of sedation in hours
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - sedation
大体时间：up to discharge from intensive care unit, an average of 30 days
|
dosage of sedation, cumulative dosage in ml/d
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - Richmond Agitation Scale
大体时间：up to discharge from intensive care unit, an average of 30 days
|
Richmond Agitation Scale (score: +4 - -5; +4=aggressive behavior, 0=calm,-5=not reacting to verbal or physical approaches)
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
大体时间：up to discharge from intensive care unit, an average of 30 days
|
CAM-ICU (score: 0-10; more than 2 errors= delirium)
|
up to discharge from intensive care unit, an average of 30 days
|
|
Persistent Organ Dysfunction - Incidence of mechanical ventilation
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
need for ventilation
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Persistent Organ Dysfunction - Incidence of hemodynamic parameters
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
vasopressors
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Persistent Organ Dysfunction - Incidence of renal replacement therapy
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
renal replacement therapy
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of surgical reevaluation
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
surgical reevaluation
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of hemorrhage
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
hemorrhage
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of thromboembolic events
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
thromboembolic events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of cardiovascular events
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
cardiovascular events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of infection
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
infection
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of sepsis
大体时间：Hospital discharge, day 30 after study inclusion, up to 3 months
|
sepsis
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月4日
初级完成 (实际的)
2020年5月4日
研究完成 (实际的)
2020年5月4日
研究注册日期
首次提交
2019年11月7日
首先提交符合 QC 标准的
2019年11月25日
首次发布 (实际的)
2019年11月29日
研究记录更新
最后更新发布 (实际的)
2022年5月26日
上次提交的符合 QC 标准的更新
2022年5月25日
最后验证
2022年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.