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Completed

NCT Number: NCT04180852

Investigating Nutrition and Functional Outcome in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Functional tests without clinical consequence for the patients therapy

Other

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.

Primary outcomes

  1. Nutritional status - basic demographics

    Time frame: at Study inclusion

    Chart review

  2. Nutritional Status - nutritional screening

    Time frame: intensive care unit (ICU) admission, up to 1 week

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

  3. Nutritional Status - nutritional risk in the critically ill (NUTRIC)

    Time frame: 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

  4. Nutritional Status - Waist and mid-arm circumferences

    Time frame: Study inclusion, up to 1 week

    Waist and mid-arm circumferences

  5. Differences of dosage of nutrition

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

    Cumulative delivery of macronutrients by infusion rates

  6. Differences of dosage of nutrition

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

    Cumulative delivery of macronutrients by cumulative count of macronutrients

  7. Differences of dosage of nutrition

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

    Cumulative delivery of macronutrients by nutrition used

  8. Timing of nutrition

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

    Chart Review- start and stop times

  9. Timing of nutrition - reason for discontinuation

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

    Chart review

  10. Differences in route of administration of nutrition

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

    Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition

  11. Incidence of Gastrointestinal symptoms

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

    Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)

  12. Incidence Blood work irregularities

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

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

  13. Incidence of Refeeding syndrome

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

    Chart review

  14. Incidence of complications related to the route of administration

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

    Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)

  15. Nutrition adequacy

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

    Rates of energy and protein received in comparison to nutritional targets Chart review

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

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

    MAC

  17. Change in Muscle mass - Quadriceps thickness

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

    ultrasound

  18. Change in Muscle mass - Quadriceps cross sectional area

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

    ultrasound

  19. Change in Muscle strength - Handgrip strength

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

    Dynamometry

  20. Change in Muscle strength - Quadriceps strength

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

    Dynamometry

  21. Change in Physical function - Functional Status Score for the ICU

    Time frame: 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)

  22. Change in Physical function - Short Physical Performance Battery

    Time frame: 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)

  23. Change in Physical function - 6-Minute Walk Test

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

    6-minute walking distance

  24. Change in Physical function - Manual Muscle Testing (MMT)

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

    MMT

  25. Change in Physical function - Katz Activities of Daily Living (ADL)

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

    ADL (Score: 0-100; the higher the more independent)

  26. Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)

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

    IADL (score 0-8; the higher the more independent)

  27. Change in Physical function - Clinical Frailty Score (CFS)

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

    CFS (score 1-9; 1= Very fit and 9=terminally ill)

  28. Change in Fat mass

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

    Thigh and abdominal fat (ultrasound)

  29. Change in Neuro-psychological function - Mini Mental State Examination (MMSE)

    Time frame: 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)

  30. Change in Neuro-psychological function - Becks Depression Inventory (BDI)

    Time frame: 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)

  31. Quality of life - Short Form 36 (SF-36)

    Time frame: day 30 after study inclusion

    SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)

  32. Quality of life - Living location

    Time frame: 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.

Secondary outcomes

  1. Mortality Rate

    Time frame: up to 30 days after study inclusion

    Mortality

  2. Length of stay - intensive care unit length of stay

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

    ICU length of stay

  3. Length of stay - Hospital length of stay

    Time frame: Hospital discharge, an average of 60 days

    Hospital length of stay

  4. Readmission - ICU readmission rate

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

    ICU readmission rate

  5. Readmission - Hospital readmission rate

    Time frame: up to 30 days after study inclusion, up to 3 months

    Hospital readmission rate

  6. Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)

    Time frame: 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)

  7. Acute organ dysfunction - hemodynamic parameters

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

    blood pressure in mmHg

  8. Acute organ dysfunction - hemodynamic parameters

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

    vasopressors, cumulative dosage in ml/d

  9. Acute organ dysfunction - hemodynamic parameters

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

    heart rate bpm

  10. Acute organ dysfunction - incidence of ventilation

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

    mode of ventilation

  11. Acute organ dysfunction - duration of ventilation

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

    hours of ventilation

  12. Acute organ dysfunction - sedation

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

    duration of sedation in hours

  13. Acute organ dysfunction - sedation

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

    dosage of sedation, cumulative dosage in ml/d

  14. Acute organ dysfunction - Richmond Agitation Scale

    Time frame: 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)

  15. Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)

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

    CAM-ICU (score: 0-10; more than 2 errors= delirium)

  16. Persistent Organ Dysfunction - Incidence of mechanical ventilation

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

    need for ventilation

  17. Persistent Organ Dysfunction - Incidence of hemodynamic parameters

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

    vasopressors

  18. Persistent Organ Dysfunction - Incidence of renal replacement therapy

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

    renal replacement therapy

  19. Complications - Rate of surgical reevaluation

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

    surgical reevaluation

  20. Complications - Rate of hemorrhage

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

    hemorrhage

  21. Complications - Rate of thromboembolic events

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

    thromboembolic events

  22. Complications - Rate of cardiovascular events

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

    cardiovascular events

  23. Complications - Rate of infection

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

    infection

  24. Complications - Rate of sepsis

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

    sepsis

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Acronym: INFO

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2019
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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