Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)
25 de maio de 2022 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
100
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
NRW
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Aachen, NRW, Alemanha, 52074
- RWTH Aachen University Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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
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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.
|
|
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:
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Nutritional status - basic demographics
Prazo: at Study inclusion
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Chart review
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at Study inclusion
|
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Nutritional Status - nutritional screening
Prazo: 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)
Prazo: 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
Prazo: Study inclusion, up to 1 week
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Waist and mid-arm circumferences
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Study inclusion, up to 1 week
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Differences of dosage of nutrition
Prazo: until discharge from intensive care unit, an average of 30 days
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Cumulative delivery of macronutrients by infusion rates
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until discharge from intensive care unit, an average of 30 days
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Differences of dosage of nutrition
Prazo: 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
|
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Differences of dosage of nutrition
Prazo: until discharge from intensive care unit, an average of 30 days
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Cumulative delivery of macronutrients by nutrition used
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until discharge from intensive care unit, an average of 30 days
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Timing of nutrition
Prazo: until discharge from intensive care unit, an average of 30 days
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: discharge from intensive care unit, an average of 30 days
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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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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 strength - Handgrip strength
Prazo: discharge from intensive care unit and hospital discharge, up to 3 months
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Dynamometry
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discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Muscle strength - Quadriceps strength
Prazo: discharge from intensive care unit and hospital discharge, up to 3 months
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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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: day 30 after study inclusion
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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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mortality Rate
Prazo: 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
Prazo: discharge from intensive care unit, an average of 30 days
|
ICU length of stay
|
discharge from intensive care unit, an average of 30 days
|
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Length of stay - Hospital length of stay
Prazo: 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
Prazo: Hospital discharge, day 30 after study inclusion, up to 3 months
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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
Prazo: up to 30 days after study inclusion, up to 3 months
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Hospital readmission rate
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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)
Prazo: up to discharge from intensive care unit, an average of 30 days
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daily records (score 0-24; 0=normal function and 24= massively impaired function)
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up to discharge from intensive care unit, an average of 30 days
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Acute organ dysfunction - hemodynamic parameters
Prazo: up to discharge from intensive care unit, an average of 30 days
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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
Prazo: up to discharge from intensive care unit, an average of 30 days
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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
Prazo: 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
Prazo: 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
Prazo: 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
|
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Acute organ dysfunction - sedation
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
|
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Persistent Organ Dysfunction - Incidence of mechanical ventilation
Prazo: 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
|
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Persistent Organ Dysfunction - Incidence of hemodynamic parameters
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Hospital discharge, day 30 after study inclusion, up to 3 months
|
cardiovascular events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
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Complications - Rate of infection
Prazo: 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
Prazo: Hospital discharge, day 30 after study inclusion, up to 3 months
|
sepsis
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
4 de janeiro de 2019
Conclusão Primária (Real)
4 de maio de 2020
Conclusão do estudo (Real)
4 de maio de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
7 de novembro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de novembro de 2019
Primeira postagem (Real)
29 de novembro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
26 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de maio de 2022
Última verificação
1 de maio de 2022
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 19-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Não
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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