Investigating Nutrition and Functional Outcome in Critically Ill Patients

RWTH Aachen University100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Neurosurgical Patients Elderly Patients Obese Patients Cardiac Surgery Patients Abdominal Surgery Patients

Interventions

Functional tests without clinical consequence for the patients therapyOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

Nutritional status - basic demographics

Chart review

Time frame: at Study inclusion

Nutritional Status - nutritional screening

Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)

Time frame: 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

Time frame: ICU admission, up to 1 week

Nutritional Status - Waist and mid-arm circumferences

Waist and mid-arm circumferences

Time frame: Study inclusion, up to 1 week

Differences of dosage of nutrition

Cumulative delivery of macronutrients by infusion rates

Time frame: 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

Time frame: until discharge from intensive care unit, an average of 30 days

Differences of dosage of nutrition

Cumulative delivery of macronutrients by nutrition used

Time frame: until discharge from intensive care unit, an average of 30 days

Timing of nutrition

Chart Review- start and stop times

Time frame: until discharge from intensive care unit, an average of 30 days

Data from ClinicalTrials.gov

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Timing of nutrition - reason for discontinuation

Chart review

Time frame: 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

Time frame: 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)

Time frame: discharge from intensive care unit, an average of 30 days

Incidence Blood work irregularities

Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)

Time frame: discharge from intensive care unit, an average of 30 days

Incidence of Refeeding syndrome

Chart review

Time frame: 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)

Time frame: 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

Time frame: discharge from intensive care unit, an average of 30 days

Change in Muscle mass - Mid-arm circumference (MAC)

MAC

Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

Change in Muscle mass - Quadriceps thickness

ultrasound

Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

Change in Muscle mass - Quadriceps cross sectional area

ultrasound

Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months

Change in Muscle strength - Handgrip strength

Dynamometry

Time frame: discharge from intensive care unit and hospital discharge, up to 3 months

Change in Muscle strength - Quadriceps strength

Dynamometry

Time frame: 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)

Time frame: 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)

Time frame: discharge from intensive care unit and hospital discharge, up to 3 months

Change in Physical function - 6-Minute Walk Test

6-minute walking distance

Time frame: discharge from intensive care unit and hospital discharge, up to 3 months

Change in Physical function - Manual Muscle Testing (MMT)

MMT

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months

Change in Fat mass

Thigh and abdominal fat (ultrasound)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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.

Time frame: day 30 after study inclusion

Secondary Outcomes

Mortality Rate

Mortality

Time frame: up to 30 days after study inclusion

Length of stay - intensive care unit length of stay

ICU length of stay

Time frame: discharge from intensive care unit, an average of 30 days

Length of stay - Hospital length of stay

Hospital length of stay

Time frame: Hospital discharge, an average of 60 days

Readmission - ICU readmission rate

ICU readmission rate

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Readmission - Hospital readmission rate

Hospital readmission rate

Time frame: 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)

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - hemodynamic parameters

blood pressure in mmHg

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - hemodynamic parameters

vasopressors, cumulative dosage in ml/d

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - hemodynamic parameters

heart rate bpm

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - incidence of ventilation

mode of ventilation

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - duration of ventilation

hours of ventilation

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - sedation

duration of sedation in hours

Time frame: up to discharge from intensive care unit, an average of 30 days

Acute organ dysfunction - sedation

dosage of sedation, cumulative dosage in ml/d

Time frame: 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)

Time frame: 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)

Time frame: up to discharge from intensive care unit, an average of 30 days

Persistent Organ Dysfunction - Incidence of mechanical ventilation

need for ventilation

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Persistent Organ Dysfunction - Incidence of hemodynamic parameters

vasopressors

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Persistent Organ Dysfunction - Incidence of renal replacement therapy

renal replacement therapy

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of surgical reevaluation

surgical reevaluation

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of hemorrhage

hemorrhage

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of thromboembolic events

thromboembolic events

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of cardiovascular events

cardiovascular events

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of infection

infection

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months

Complications - Rate of sepsis

sepsis

Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months