Investigating Nutrition and Functional Outcome in Critically Ill Patients
- Conditions
- Obese PatientsElderly PatientsAbdominal Surgery PatientsNeurosurgical PatientsCardiac Surgery Patients
- Interventions
- Other: Functional tests without clinical consequence for the patients therapy
- Registration Number
- NCT04180852
- Lead Sponsor
- RWTH Aachen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Obese patients Functional tests without clinical consequence for the patients therapy BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2 Neurosurgical patients Functional tests without clinical consequence for the patients therapy Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups: 1. Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage) 2. Acute and severe head trauma with an initial Glasgow Coma Scale ≤10 Cardiac surgery patients Functional tests without clinical consequence for the patients therapy Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups: 1. Coronary revascularization (coronary artery bypass graft) 2. Heart valve surgery 3. Combined or complex heart surgery Abdominal surgical patients Functional tests without clinical consequence for the patients therapy Admission to the abdominal surgery ICU after abdominal surgery Elderly patients Functional tests without clinical consequence for the patients therapy Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years
- Primary Outcome Measures
Name Time Method 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)
Timing of nutrition until discharge from intensive care unit, an average of 30 days Chart Review- start and stop times
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 - 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 Fat mass Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months Thigh and abdominal fat (ultrasound)
Nutritional status - basic demographics at Study inclusion Chart review
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
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)
Differences of dosage of nutrition until discharge from intensive care unit, an average of 30 days Cumulative delivery of macronutrients by nutrition used
Timing of nutrition - reason for discontinuation at discharge from intensive care unit, an average of 30 days Chart review
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)
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
Incidence Blood work irregularities discharge from intensive care unit, an average of 30 days Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
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 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 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 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 Muscle strength - Quadriceps strength discharge from intensive care unit and hospital discharge, up to 3 months Dynamometry
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 - 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 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)
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)
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 - 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.
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)
- Secondary Outcome Measures
Name Time Method 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 - 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)
Mortality Rate up to 30 days after study inclusion Mortality
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
Acute organ dysfunction - hemodynamic parameters up to discharge from intensive care unit, an average of 30 days heart rate bpm
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 hemorrhage Hospital discharge, day 30 after study inclusion, up to 3 months hemorrhage
Length of stay - intensive care unit length of stay discharge from intensive care unit, an average of 30 days ICU length of stay
Acute organ dysfunction - sedation up to discharge from intensive care unit, an average of 30 days dosage of sedation, cumulative dosage in ml/d
Complications - Rate of cardiovascular events Hospital discharge, day 30 after study inclusion, up to 3 months cardiovascular events
Acute organ dysfunction - incidence of ventilation up to discharge from intensive care unit, an average of 30 days mode of ventilation
Acute organ dysfunction - duration of ventilation up to discharge from intensive care unit, an average of 30 days hours of ventilation
Complications - Rate of surgical reevaluation Hospital discharge, day 30 after study inclusion, up to 3 months surgical reevaluation
Complications - Rate of sepsis Hospital discharge, day 30 after study inclusion, up to 3 months sepsis
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
Complications - Rate of thromboembolic events Hospital discharge, day 30 after study inclusion, up to 3 months thromboembolic events
Complications - Rate of infection Hospital discharge, day 30 after study inclusion, up to 3 months infection
Trial Locations
- Locations (1)
RWTH Aachen University Hospital
🇩🇪Aachen, NRW, Germany