RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074, Germany
NCT Number: NCT04180852
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Aachen, North Rhine-Westphalia, 52074, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: at Study inclusion
Chart review
Time frame: intensive care unit (ICU) admission, up to 1 week
Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
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
Time frame: Study inclusion, up to 1 week
Waist and mid-arm circumferences
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by infusion rates
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by cumulative count of macronutrients
Time frame: until discharge from intensive care unit, an average of 30 days
Cumulative delivery of macronutrients by nutrition used
Time frame: until discharge from intensive care unit, an average of 30 days
Chart Review- start and stop times
Time frame: at discharge from intensive care unit, an average of 30 days
Chart review
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
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)
Time frame: discharge from intensive care unit, an average of 30 days
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
Time frame: discharge from intensive care unit, an average of 30 days
Chart review
Time frame: discharge from intensive care unit, an average of 30 days
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
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
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
MAC
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
ultrasound
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
Dynamometry
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)
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)
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
6-minute walking distance
Time frame: discharge from intensive care unit and hospital discharge, up to 3 months
MMT
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
ADL (Score: 0-100; the higher the more independent)
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
IADL (score 0-8; the higher the more independent)
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)
Time frame: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Thigh and abdominal fat (ultrasound)
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)
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)
Time frame: day 30 after study inclusion
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
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.
Time frame: up to 30 days after study inclusion
Mortality
Time frame: discharge from intensive care unit, an average of 30 days
ICU length of stay
Time frame: Hospital discharge, an average of 60 days
Hospital length of stay
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
ICU readmission rate
Time frame: up to 30 days after study inclusion, up to 3 months
Hospital readmission rate
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)
Time frame: up to discharge from intensive care unit, an average of 30 days
blood pressure in mmHg
Time frame: up to discharge from intensive care unit, an average of 30 days
vasopressors, cumulative dosage in ml/d
Time frame: up to discharge from intensive care unit, an average of 30 days
heart rate bpm
Time frame: up to discharge from intensive care unit, an average of 30 days
mode of ventilation
Time frame: up to discharge from intensive care unit, an average of 30 days
hours of ventilation
Time frame: up to discharge from intensive care unit, an average of 30 days
duration of sedation in hours
Time frame: up to discharge from intensive care unit, an average of 30 days
dosage of sedation, cumulative dosage in ml/d
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)
Time frame: up to discharge from intensive care unit, an average of 30 days
CAM-ICU (score: 0-10; more than 2 errors= delirium)
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
need for ventilation
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
vasopressors
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
renal replacement therapy
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
surgical reevaluation
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
hemorrhage
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
thromboembolic events
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
cardiovascular events
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
infection
Time frame: Hospital discharge, day 30 after study inclusion, up to 3 months
sepsis
RWTH Aachen University
Other
Acronym: INFO
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.
Published trials that share one or more normalized conditions with this study.
NCT06591624
Neurosurgical Patients, Neurosurgical Procedures
Chiang Mai, Thailand
View Trial DetailsNCT05230641
Cardiovascular Diseases, Hypotension
Bangalore, Karnataka, India
View Trial DetailsNCT06727435
Agnosia, Craniotomy
Beijing, China
View Trial DetailsNCT06584097
Neurosurgical Patients
Milan, Italy
View Trial Details