Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)
25. mai 2022 oppdatert av: Christian Stoppe, RWTH Aachen University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
100
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
NRW
-
Aachen, NRW, Tyskland, 52074
- RWTH Aachen University Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Neurosurgical patients
Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups:
|
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.
|
|
Elderly patients
Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years
|
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.
|
|
Obese patients
BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2
|
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.
|
|
Cardiac surgery patients
Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups:
|
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.
|
|
Abdominal surgical patients
Admission to the abdominal surgery ICU after abdominal surgery
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nutritional status - basic demographics
Tidsramme: at Study inclusion
|
Chart review
|
at Study inclusion
|
|
Nutritional Status - nutritional screening
Tidsramme: intensive care unit (ICU) admission, up to 1 week
|
Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)
|
intensive care unit (ICU) admission, up to 1 week
|
|
Nutritional Status - nutritional risk in the critically ill (NUTRIC)
Tidsramme: 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
|
ICU admission, up to 1 week
|
|
Nutritional Status - Waist and mid-arm circumferences
Tidsramme: Study inclusion, up to 1 week
|
Waist and mid-arm circumferences
|
Study inclusion, up to 1 week
|
|
Differences of dosage of nutrition
Tidsramme: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by infusion rates
|
until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
Tidsramme: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by cumulative count of macronutrients
|
until discharge from intensive care unit, an average of 30 days
|
|
Differences of dosage of nutrition
Tidsramme: until discharge from intensive care unit, an average of 30 days
|
Cumulative delivery of macronutrients by nutrition used
|
until discharge from intensive care unit, an average of 30 days
|
|
Timing of nutrition
Tidsramme: until discharge from intensive care unit, an average of 30 days
|
Chart Review- start and stop times
|
until discharge from intensive care unit, an average of 30 days
|
|
Timing of nutrition - reason for discontinuation
Tidsramme: at discharge from intensive care unit, an average of 30 days
|
Chart review
|
at discharge from intensive care unit, an average of 30 days
|
|
Differences in route of administration of nutrition
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of Gastrointestinal symptoms
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence Blood work irregularities
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of Refeeding syndrome
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Chart review
|
discharge from intensive care unit, an average of 30 days
|
|
Incidence of complications related to the route of administration
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)
|
discharge from intensive care unit, an average of 30 days
|
|
Nutrition adequacy
Tidsramme: discharge from intensive care unit, an average of 30 days
|
Rates of energy and protein received in comparison to nutritional targets Chart review
|
discharge from intensive care unit, an average of 30 days
|
|
Change in Muscle mass - Mid-arm circumference (MAC)
Tidsramme: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
MAC
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle mass - Quadriceps thickness
Tidsramme: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
ultrasound
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle mass - Quadriceps cross sectional area
Tidsramme: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
ultrasound
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle strength - Handgrip strength
Tidsramme: discharge from intensive care unit and hospital discharge, up to 3 months
|
Dynamometry
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Muscle strength - Quadriceps strength
Tidsramme: discharge from intensive care unit and hospital discharge, up to 3 months
|
Dynamometry
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Functional Status Score for the ICU
Tidsramme: 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)
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Short Physical Performance Battery
Tidsramme: 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)
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - 6-Minute Walk Test
Tidsramme: discharge from intensive care unit and hospital discharge, up to 3 months
|
6-minute walking distance
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Manual Muscle Testing (MMT)
Tidsramme: discharge from intensive care unit and hospital discharge, up to 3 months
|
MMT
|
discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Physical function - Katz Activities of Daily Living (ADL)
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
ADL (Score: 0-100; the higher the more independent)
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
IADL (score 0-8; the higher the more independent)
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Physical function - Clinical Frailty Score (CFS)
Tidsramme: Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
|
CFS (score 1-9; 1= Very fit and 9=terminally ill)
|
Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Change in Fat mass
Tidsramme: Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
Thigh and abdominal fat (ultrasound)
|
Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
|
|
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)
Tidsramme: 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)
|
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)
Tidsramme: 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)
|
discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Quality of life - Short Form 36 (SF-36)
Tidsramme: day 30 after study inclusion
|
SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)
|
day 30 after study inclusion
|
|
Quality of life - Living location
Tidsramme: 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.
|
day 30 after study inclusion
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mortality Rate
Tidsramme: up to 30 days after study inclusion
|
Mortality
|
up to 30 days after study inclusion
|
|
Length of stay - intensive care unit length of stay
Tidsramme: discharge from intensive care unit, an average of 30 days
|
ICU length of stay
|
discharge from intensive care unit, an average of 30 days
|
|
Length of stay - Hospital length of stay
Tidsramme: Hospital discharge, an average of 60 days
|
Hospital length of stay
|
Hospital discharge, an average of 60 days
|
|
Readmission - ICU readmission rate
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
ICU readmission rate
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Readmission - Hospital readmission rate
Tidsramme: up to 30 days after study inclusion, up to 3 months
|
Hospital readmission rate
|
up to 30 days after study inclusion, up to 3 months
|
|
Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)
Tidsramme: 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)
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - hemodynamic parameters
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
blood pressure in mmHg
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - hemodynamic parameters
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
vasopressors, cumulative dosage in ml/d
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - hemodynamic parameters
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
heart rate bpm
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - incidence of ventilation
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
mode of ventilation
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - duration of ventilation
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
hours of ventilation
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - sedation
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
duration of sedation in hours
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - sedation
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
dosage of sedation, cumulative dosage in ml/d
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - Richmond Agitation Scale
Tidsramme: 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)
|
up to discharge from intensive care unit, an average of 30 days
|
|
Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)
Tidsramme: up to discharge from intensive care unit, an average of 30 days
|
CAM-ICU (score: 0-10; more than 2 errors= delirium)
|
up to discharge from intensive care unit, an average of 30 days
|
|
Persistent Organ Dysfunction - Incidence of mechanical ventilation
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
need for ventilation
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Persistent Organ Dysfunction - Incidence of hemodynamic parameters
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
vasopressors
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Persistent Organ Dysfunction - Incidence of renal replacement therapy
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
renal replacement therapy
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of surgical reevaluation
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
surgical reevaluation
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of hemorrhage
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
hemorrhage
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of thromboembolic events
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
thromboembolic events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of cardiovascular events
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
cardiovascular events
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of infection
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
infection
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
|
Complications - Rate of sepsis
Tidsramme: Hospital discharge, day 30 after study inclusion, up to 3 months
|
sepsis
|
Hospital discharge, day 30 after study inclusion, up to 3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. januar 2019
Primær fullføring (Faktiske)
4. mai 2020
Studiet fullført (Faktiske)
4. mai 2020
Datoer for studieregistrering
Først innsendt
7. november 2019
Først innsendt som oppfylte QC-kriteriene
25. november 2019
Først lagt ut (Faktiske)
29. november 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. mai 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. mai 2022
Sist bekreftet
1. mai 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 19-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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