Investigating Nutrition and Functional Outcome in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating Nutrition and Functional Outcome in Critically Ill Patients

Conditions
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Abdominal Surgery Patients, Neurosurgical Patients, Elderly Patients, Obese Patients, Cardiac Surgery Patients

Intervention / Treatment
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* Other: Functional tests without clinical consequence for the patients therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurosurgical patients<br>Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups: Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage) Acute and severe head trauma with an initial Glasgow Coma Scale ≤10 | Other: Functional tests without clinical consequence for the patients therapy<br>* 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.<br>|
| Elderly patients<br>Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years | Other: Functional tests without clinical consequence for the patients therapy<br>* 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.<br>|
| Obese patients<br>BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2 | Other: Functional tests without clinical consequence for the patients therapy<br>* 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.<br>|
| Cardiac surgery patients<br>Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups: Coronary revascularization (coronary artery bypass graft) Heart valve surgery Combined or complex heart surgery | Other: Functional tests without clinical consequence for the patients therapy<br>* 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.<br>|
| Abdominal surgical patients<br>Admission to the abdominal surgery ICU after abdominal surgery | Other: Functional tests without clinical consequence for the patients therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status - basic demographics | Chart review | at Study inclusion | 
| Nutritional Status - nutritional screening | Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk) | intensive care unit (ICU) admission, up to 1 week | 
| Nutritional Status - nutritional risk in the critically ill (NUTRIC) | 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 | Waist and mid-arm circumferences | Study inclusion, up to 1 week | 
| Differences of dosage of nutrition | Cumulative delivery of macronutrients by infusion rates | until discharge from intensive care unit, an average of 30 days | 
| Differences of dosage of nutrition | 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 | Cumulative delivery of macronutrients by nutrition used | until discharge from intensive care unit, an average of 30 days | 
| Timing of nutrition | Chart Review- start and stop times | until discharge from intensive care unit, an average of 30 days | 
| Timing of nutrition - reason for discontinuation | Chart review | at discharge from intensive care unit, an average of 30 days | 
| Differences in route of administration of nutrition | Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition | discharge from intensive care unit, an average of 30 days | 
| Incidence of Gastrointestinal symptoms | 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 | Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia) | discharge from intensive care unit, an average of 30 days | 
| Incidence of Refeeding syndrome | Chart review | discharge from intensive care unit, an average of 30 days | 
| Incidence of complications related to the route of administration | Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes) | discharge from intensive care unit, an average of 30 days | 
| Nutrition adequacy | 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) | MAC | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Muscle mass - Quadriceps thickness | ultrasound | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Muscle mass - Quadriceps cross sectional area | ultrasound | Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Muscle strength - Handgrip strength | Dynamometry | discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Muscle strength - Quadriceps strength | Dynamometry | discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Physical function - Functional Status Score for the ICU | 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 | 
| Change in Physical function - Short Physical Performance Battery | Short Physical Performance Battery (SPPB) (Score: 0-12; 0=worst performance and 12=best performance) | discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Physical function - 6-Minute Walk Test | 6-minute walking distance | discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Physical function - Manual Muscle Testing (MMT) | MMT | discharge from intensive care unit and hospital discharge, up to 3 months | 
| Change in Physical function - Katz Activities of Daily Living (ADL) | ADL (Score: 0-100; the higher the more independent) | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL) | IADL (score 0-8; the higher the more independent) | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Change in Physical function - Clinical Frailty Score (CFS) | 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 | 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) | 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) | 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) | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Mortality | up to 30 days after study inclusion | 
| Length of stay - intensive care unit length of stay | ICU length of stay | discharge from intensive care unit, an average of 30 days | 
| Length of stay - Hospital length of stay | Hospital length of stay | Hospital discharge, an average of 60 days | 
| Readmission - ICU readmission rate | ICU readmission rate | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Readmission - Hospital readmission rate | 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) | 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 | blood pressure in mmHg | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - hemodynamic parameters | vasopressors, cumulative dosage in ml/d | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - hemodynamic parameters | heart rate bpm | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - incidence of ventilation | mode of ventilation | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - duration of ventilation | hours of ventilation | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - sedation | duration of sedation in hours | up to discharge from intensive care unit, an average of 30 days | 
| Acute organ dysfunction - sedation | 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 | 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) | 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 | need for ventilation | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Persistent Organ Dysfunction - Incidence of hemodynamic parameters | vasopressors | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Persistent Organ Dysfunction - Incidence of renal replacement therapy | renal replacement therapy | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of surgical reevaluation | surgical reevaluation | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of hemorrhage | hemorrhage | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of thromboembolic events | thromboembolic events | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of cardiovascular events | cardiovascular events | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of infection | infection | Hospital discharge, day 30 after study inclusion, up to 3 months | 
| Complications - Rate of sepsis | sepsis | Hospital discharge, day 30 after study inclusion, up to 3 months |