Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)
25 mei 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
100
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
NRW
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Aachen, NRW, Duitsland, 52074
- RWTH Aachen University Hospital
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Neurosurgical patients
Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies 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.
|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Nutritional status - basic demographics
Tijdsspanne: at Study inclusion
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Chart review
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at Study inclusion
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Nutritional Status - nutritional screening
Tijdsspanne: 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
|
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Nutritional Status - nutritional risk in the critically ill (NUTRIC)
Tijdsspanne: ICU admission, up to 1 week
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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
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ICU admission, up to 1 week
|
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Nutritional Status - Waist and mid-arm circumferences
Tijdsspanne: Study inclusion, up to 1 week
|
Waist and mid-arm circumferences
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Study inclusion, up to 1 week
|
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Differences of dosage of nutrition
Tijdsspanne: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by infusion rates
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until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
Tijdsspanne: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by cumulative count of macronutrients
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until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
Tijdsspanne: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by nutrition used
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until discharge from intensive care unit, an average of 30 days
|
|
Timing of nutrition
Tijdsspanne: 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
|
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Timing of nutrition - reason for discontinuation
Tijdsspanne: at discharge from intensive care unit, an average of 30 days
|
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
Tijdsspanne: discharge from intensive care unit, an average of 30 days
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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
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Incidence of Gastrointestinal symptoms
Tijdsspanne: discharge from intensive care unit, an average of 30 days
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Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
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discharge from intensive care unit, an average of 30 days
|
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Incidence Blood work irregularities
Tijdsspanne: discharge from intensive care unit, an average of 30 days
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Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
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discharge from intensive care unit, an average of 30 days
|
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Incidence of Refeeding syndrome
Tijdsspanne: discharge from intensive care unit, an average of 30 days
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Chart review
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discharge from intensive care unit, an average of 30 days
|
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Incidence of complications related to the route of administration
Tijdsspanne: discharge from intensive care unit, an average of 30 days
|
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
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discharge from intensive care unit, an average of 30 days
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Nutrition adequacy
Tijdsspanne: discharge from intensive care unit, an average of 30 days
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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
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Change in Muscle mass - Mid-arm circumference (MAC)
Tijdsspanne: 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
|
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Change in Muscle mass - Quadriceps thickness
Tijdsspanne: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
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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
Tijdsspanne: 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 strength - Handgrip strength
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
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Dynamometry
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Muscle strength - Quadriceps strength
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
|
Dynamometry
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discharge from intensive care unit and hospital discharge, up to 3 months
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Change in Physical function - Functional Status Score for the ICU
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
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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
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
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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
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
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6-minute walking distance
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discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Physical function - Manual Muscle Testing (MMT)
Tijdsspanne: discharge from intensive care unit and hospital discharge, up to 3 months
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MMT
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discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Physical function - Katz Activities of Daily Living (ADL)
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
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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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
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Thigh and abdominal fat (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 Neuro-psychological function - Mini Mental State Examination (MMSE)
Tijdsspanne: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
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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)
Tijdsspanne: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
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BDI (Score 0-63; 0= no depression and 63= severe depression)
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discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Quality of life - Short Form 36 (SF-36)
Tijdsspanne: day 30 after study inclusion
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SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
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day 30 after study inclusion
|
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Quality of life - Living location
Tijdsspanne: 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.
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day 30 after study inclusion
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mortality Rate
Tijdsspanne: up to 30 days after study inclusion
|
Mortality
|
up to 30 days after study inclusion
|
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Length of stay - intensive care unit length of stay
Tijdsspanne: discharge from intensive care unit, an average of 30 days
|
ICU length of stay
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discharge from intensive care unit, an average of 30 days
|
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Length of stay - Hospital length of stay
Tijdsspanne: Hospital discharge, an average of 60 days
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Hospital length of stay
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Hospital discharge, an average of 60 days
|
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Readmission - ICU readmission rate
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
|
ICU readmission rate
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Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Readmission - Hospital readmission rate
Tijdsspanne: 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
|
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Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
Tijdsspanne: 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
Tijdsspanne: 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
|
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Acute organ dysfunction - hemodynamic parameters
Tijdsspanne: 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
|
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Acute organ dysfunction - hemodynamic parameters
Tijdsspanne: 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
|
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Acute organ dysfunction - incidence of ventilation
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Acute organ dysfunction - sedation
Tijdsspanne: 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
|
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Acute organ dysfunction - Richmond Agitation Scale
Tijdsspanne: 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
|
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Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Complications - Rate of surgical reevaluation
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
|
surgical reevaluation
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Complications - Rate of hemorrhage
Tijdsspanne: 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
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
|
thromboembolic events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Complications - Rate of cardiovascular events
Tijdsspanne: 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
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
|
infection
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Complications - Rate of sepsis
Tijdsspanne: Hospital discharge, day 30 after study inclusion, up to 3 months
|
sepsis
|
Hospital discharge, day 30 after study inclusion, up to 3 months
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
4 januari 2019
Primaire voltooiing (Werkelijk)
4 mei 2020
Studie voltooiing (Werkelijk)
4 mei 2020
Studieregistratiedata
Eerst ingediend
7 november 2019
Eerst ingediend dat voldeed aan de QC-criteria
25 november 2019
Eerst geplaatst (Werkelijk)
29 november 2019
Updates van studierecords
Laatste update geplaatst (Werkelijk)
26 mei 2022
Laatste update ingediend die voldeed aan QC-criteria
25 mei 2022
Laatst geverifieerd
1 mei 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 19-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Nee
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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