Abdominal Surgery Patients, Cardiac Surgery Patients, Elderly Patients, Neurosurgical Patients, Obese Patients
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERFunctional tests without clinical consequence for the patients therapy
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.
Sponsors
RWTH Aachen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life - Living location | 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. |
| Incidence of Gastrointestinal symptoms | discharge from intensive care unit, an average of 30 days | Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia) |
| Incidence Blood work irregularities | discharge from intensive care unit, an average of 30 days | Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia) |
| Incidence of Refeeding syndrome | discharge from intensive care unit, an average of 30 days | Chart review |
| Incidence of complications related to the route of administration | discharge from intensive care unit, an average of 30 days | Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes) |
| Nutrition adequacy | discharge from intensive care unit, an average of 30 days | Rates of energy and protein received in comparison to nutritional targets Chart review |
| Change in Muscle mass - Mid-arm circumference (MAC) | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | MAC |
| Change in Muscle mass - Quadriceps thickness | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | ultrasound |
| Change in Muscle mass - Quadriceps cross sectional area | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | ultrasound |
| Change in Muscle strength - Handgrip strength | discharge from intensive care unit and hospital discharge, up to 3 months | Dynamometry |
| Change in Muscle strength - Quadriceps strength | discharge from intensive care unit and hospital discharge, up to 3 months | Dynamometry |
| Change in Physical function - Functional Status Score for the ICU | 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) |
| Change in Physical function - Short Physical Performance Battery | 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) |
| Change in Physical function - 6-Minute Walk Test | discharge from intensive care unit and hospital discharge, up to 3 months | 6-minute walking distance |
| Change in Physical function - Manual Muscle Testing (MMT) | discharge from intensive care unit and hospital discharge, up to 3 months | MMT |
| Change in Physical function - Katz Activities of Daily Living (ADL) | Hospital discharge, day 30 after study inclusion, up to 3 months | ADL (Score: 0-100; the higher the more independent) |
| Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL) | Hospital discharge, day 30 after study inclusion, up to 3 months | IADL (score 0-8; the higher the more independent) |
| Change in Physical function - Clinical Frailty Score (CFS) | Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months | CFS (score 1-9; 1= Very fit and 9=terminally ill) |
| Change in Fat mass | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | Thigh and abdominal fat (ultrasound) |
| Change in Neuro-psychological function - Mini Mental State Examination (MMSE) | 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) |
| Change in Neuro-psychological function - Becks Depression Inventory (BDI) | 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) |
| Quality of life - Short Form 36 (SF-36) | day 30 after study inclusion | SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited) |
| Nutritional status - basic demographics | at Study inclusion | Chart review |
| Nutritional Status - nutritional screening | intensive care unit (ICU) admission, up to 1 week | Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk) |
| Nutritional Status - nutritional risk in the critically ill (NUTRIC) | 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 |
| Nutritional Status - Waist and mid-arm circumferences | Study inclusion, up to 1 week | Waist and mid-arm circumferences |
| Differences of dosage of nutrition | until discharge from intensive care unit, an average of 30 days | Cumulative delivery of macronutrients by infusion rates |
| Timing of nutrition | until discharge from intensive care unit, an average of 30 days | Chart Review- start and stop times |
| Timing of nutrition - reason for discontinuation | at discharge from intensive care unit, an average of 30 days | Chart review |
| Differences in route of administration of nutrition | discharge from intensive care unit, an average of 30 days | Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute organ dysfunction - duration of ventilation | up to discharge from intensive care unit, an average of 30 days | hours of ventilation |
| Acute organ dysfunction - sedation | up to discharge from intensive care unit, an average of 30 days | duration of sedation in hours |
| Mortality Rate | up to 30 days after study inclusion | Mortality |
| Length of stay - intensive care unit length of stay | discharge from intensive care unit, an average of 30 days | ICU length of stay |
| Length of stay - Hospital length of stay | Hospital discharge, an average of 60 days | Hospital length of stay |
| Readmission - ICU readmission rate | Hospital discharge, day 30 after study inclusion, up to 3 months | ICU readmission rate |
| Readmission - Hospital readmission rate | up to 30 days after study inclusion, up to 3 months | Hospital readmission rate |
| Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score) | 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) |
| Acute organ dysfunction - hemodynamic parameters | up to discharge from intensive care unit, an average of 30 days | blood pressure in mmHg |
| Acute organ dysfunction - Richmond Agitation Scale | 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) |
| Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU) | up to discharge from intensive care unit, an average of 30 days | CAM-ICU (score: 0-10; more than 2 errors= delirium) |
| Persistent Organ Dysfunction - Incidence of mechanical ventilation | Hospital discharge, day 30 after study inclusion, up to 3 months | need for ventilation |
| Persistent Organ Dysfunction - Incidence of hemodynamic parameters | Hospital discharge, day 30 after study inclusion, up to 3 months | vasopressors |
| Persistent Organ Dysfunction - Incidence of renal replacement therapy | Hospital discharge, day 30 after study inclusion, up to 3 months | renal replacement therapy |
| Complications - Rate of surgical reevaluation | Hospital discharge, day 30 after study inclusion, up to 3 months | surgical reevaluation |
| Complications - Rate of hemorrhage | Hospital discharge, day 30 after study inclusion, up to 3 months | hemorrhage |
| Complications - Rate of thromboembolic events | Hospital discharge, day 30 after study inclusion, up to 3 months | thromboembolic events |
| Complications - Rate of cardiovascular events | Hospital discharge, day 30 after study inclusion, up to 3 months | cardiovascular events |
| Complications - Rate of infection | Hospital discharge, day 30 after study inclusion, up to 3 months | infection |
| Complications - Rate of sepsis | Hospital discharge, day 30 after study inclusion, up to 3 months | sepsis |
| Acute organ dysfunction - incidence of ventilation | up to discharge from intensive care unit, an average of 30 days | mode of ventilation |
Countries
Germany
Outcome results
None listed