Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)
25 de mayo de 2022 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
De observación
Inscripción (Actual)
100
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
NRW
-
Aachen, NRW, Alemania, 52074
- RWTH Aachen University Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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:
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nutritional status - basic demographics
Periodo de tiempo: at Study inclusion
|
Chart review
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at Study inclusion
|
|
Nutritional Status - nutritional screening
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Study inclusion, up to 1 week
|
Waist and mid-arm circumferences
|
Study inclusion, up to 1 week
|
|
Differences of dosage of nutrition
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Differences in route of administration of nutrition
Periodo de tiempo: 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
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|
Incidence of Gastrointestinal symptoms
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
discharge from intensive care unit, an average of 30 days
|
|
Change in Muscle mass - Mid-arm circumference (MAC)
Periodo de tiempo: 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
|
|
Change in Muscle mass - Quadriceps thickness
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
Change in Muscle strength - Handgrip strength
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
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Change in Physical function - Short Physical Performance Battery
Periodo de tiempo: 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
|
|
Change in Physical function - 6-Minute Walk Test
Periodo de tiempo: 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
|
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Change in Physical function - Manual Muscle Testing (MMT)
Periodo de tiempo: 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
|
|
Change in Physical function - Katz Activities of Daily Living (ADL)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mortality Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Hospital discharge, an average of 60 days
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Hospital length of stay
|
Hospital discharge, an average of 60 days
|
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Readmission - ICU readmission rate
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de enero de 2019
Finalización primaria (Actual)
4 de mayo de 2020
Finalización del estudio (Actual)
4 de mayo de 2020
Fechas de registro del estudio
Enviado por primera vez
7 de noviembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
25 de noviembre de 2019
Publicado por primera vez (Actual)
29 de noviembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
25 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 19-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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