Clinical trial NCT04180852: Investigating Nutrition and Functional Outcome in Critically Ill Patients
Official title: Investigating Nutrition and Functional Outcome in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurosurgical Patients
Elderly Patients
Obese Patients
Cardiac Surgery Patients
Abdominal Surgery Patients
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Nutritional status - basic demographics
timeFrame: at Study inclusion
measure: Nutritional Status - nutritional screening
timeFrame: intensive care unit (ICU) admission, up to 1 week
measure: Nutritional Status - nutritional risk in the critically ill (NUTRIC)
timeFrame: ICU admission, up to 1 week
measure: Nutritional Status - Waist and mid-arm circumferences
timeFrame: Study inclusion, up to 1 week
measure: Differences of dosage of nutrition
timeFrame: until discharge from intensive care unit, an average of 30 days
measure: Differences of dosage of nutrition
timeFrame: until discharge from intensive care unit, an average of 30 days
measure: Differences of dosage of nutrition
timeFrame: until discharge from intensive care unit, an average of 30 days
measure: Timing of nutrition
timeFrame: until discharge from intensive care unit, an average of 30 days
measure: Timing of nutrition - reason for discontinuation
timeFrame: at discharge from intensive care unit, an average of 30 days
measure: Differences in route of administration of nutrition
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Incidence of Gastrointestinal symptoms
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Incidence Blood work irregularities
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Incidence of Refeeding syndrome
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Incidence of complications related to the route of administration
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Nutrition adequacy
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Change in Muscle mass - Mid-arm circumference (MAC)
timeFrame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Muscle mass - Quadriceps thickness
timeFrame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Muscle mass - Quadriceps cross sectional area
timeFrame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Muscle strength - Handgrip strength
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Muscle strength - Quadriceps strength
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Physical function - Functional Status Score for the ICU
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Physical function - Short Physical Performance Battery
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Physical function - 6-Minute Walk Test
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Physical function - Manual Muscle Testing (MMT)
timeFrame: discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Physical function - Katz Activities of Daily Living (ADL)
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Change in Physical function - Clinical Frailty Score (CFS)
timeFrame: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Change in Fat mass
timeFrame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
measure: Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
timeFrame: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Change in Neuro-psychological function - Becks Depression Inventory (BDI)
timeFrame: discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Quality of life - Short Form 36 (SF-36)
timeFrame: day 30 after study inclusion
measure: Quality of life - Living location
timeFrame: day 30 after study inclusion
Secondary outcomes:
measure: Mortality Rate
timeFrame: up to 30 days after study inclusion
measure: Length of stay - intensive care unit length of stay
timeFrame: discharge from intensive care unit, an average of 30 days
measure: Length of stay - Hospital length of stay
timeFrame: Hospital discharge, an average of 60 days
measure: Readmission - ICU readmission rate
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Readmission - Hospital readmission rate
timeFrame: up to 30 days after study inclusion, up to 3 months
measure: Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - hemodynamic parameters
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - hemodynamic parameters
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - hemodynamic parameters
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - incidence of ventilation
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - duration of ventilation
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - sedation
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - sedation
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - Richmond Agitation Scale
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
timeFrame: up to discharge from intensive care unit, an average of 30 days
measure: Persistent Organ Dysfunction - Incidence of mechanical ventilation
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Persistent Organ Dysfunction - Incidence of hemodynamic parameters
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Persistent Organ Dysfunction - Incidence of renal replacement therapy
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of surgical reevaluation
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of hemorrhage
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of thromboembolic events
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of cardiovascular events
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of infection
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
measure: Complications - Rate of sepsis
timeFrame: Hospital discharge, day 30 after study inclusion, up to 3 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: RWTH Aachen University Hospital
state: NRW
Study officials:
References: