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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
観察的
入学 (実際)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
NRW
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Aachen、NRW、ドイツ、52074
- RWTH Aachen University Hospital
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
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:
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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.
|
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nutritional status - basic demographics
時間枠：at Study inclusion
|
Chart review
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at Study inclusion
|
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Nutritional Status - nutritional screening
時間枠：intensive care unit (ICU) admission, up to 1 week
|
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)
時間枠：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
時間枠：Study inclusion, up to 1 week
|
Waist and mid-arm circumferences
|
Study inclusion, up to 1 week
|
|
Differences of dosage of nutrition
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：at discharge from intensive care unit, an average of 30 days
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Chart review
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at discharge from intensive care unit, an average of 30 days
|
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Differences in route of administration of nutrition
時間枠：discharge from intensive care unit, an average of 30 days
|
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
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discharge from intensive care unit, an average of 30 days
|
|
Incidence of Gastrointestinal symptoms
時間枠：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
時間枠：discharge from intensive care unit, an average of 30 days
|
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of Refeeding syndrome
時間枠：discharge from intensive care unit, an average of 30 days
|
Chart review
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of complications related to the route of administration
時間枠：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
時間枠：discharge from intensive care unit, an average of 30 days
|
Rates of energy and protein received in comparison to nutritional targets Chart review
|
discharge from intensive care unit, an average of 30 days
|
|
Change in Muscle mass - Mid-arm circumference (MAC)
時間枠：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
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MAC
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Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle mass - Quadriceps thickness
時間枠：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 mass - Quadriceps cross sectional area
時間枠：Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
ultrasound
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle strength - Handgrip strength
時間枠：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
時間枠：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
時間枠：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
|
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Change in Physical function - Short Physical Performance Battery
時間枠：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
|
|
Change in Physical function - 6-Minute Walk Test
時間枠：discharge from intensive care unit and hospital discharge, up to 3 months
|
6-minute walking distance
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discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Manual Muscle Testing (MMT)
時間枠：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)
時間枠：Hospital discharge, day 30 after study inclusion, up to 3 months
|
ADL (Score: 0-100; the higher the more independent)
|
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)
時間枠：Hospital discharge, day 30 after study inclusion, up to 3 months
|
IADL (score 0-8; the higher the more independent)
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Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Physical function - Clinical Frailty Score (CFS)
時間枠：Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
|
CFS (score 1-9; 1= Very fit and 9=terminally ill)
|
Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Fat mass
時間枠：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)
時間枠：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)
|
discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Neuro-psychological function - Becks Depression Inventory (BDI)
時間枠：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)
時間枠：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
|
|
Quality of life - Living location
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mortality Rate
時間枠：up to 30 days after study inclusion
|
Mortality
|
up to 30 days after study inclusion
|
|
Length of stay - intensive care unit length of stay
時間枠：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
時間枠：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
時間枠：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
時間枠：up to 30 days after study inclusion, up to 3 months
|
Hospital readmission rate
|
up to 30 days after study inclusion, up to 3 months
|
|
Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
時間枠：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
|
|
Acute organ dysfunction - hemodynamic parameters
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
|
Acute organ dysfunction - duration of ventilation
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Hospital discharge, day 30 after study inclusion, up to 3 months
|
sepsis
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2019年1月4日
一次修了 (実際)
2020年5月4日
研究の完了 (実際)
2020年5月4日
試験登録日
最初に提出
2019年11月7日
QC基準を満たした最初の提出物
2019年11月25日
最初の投稿 (実際)
2019年11月29日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月26日
QC基準を満たした最後の更新が送信されました
2022年5月25日
最終確認日
2022年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。