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Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)

25 maj 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Tyskland
    • NRW
      • Aachen, NRW, Tyskland, 52074
        • RWTH Aachen University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Neurosurgical patients

Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups:

  1. Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage)
  2. Acute and severe head trauma with an initial Glasgow Coma Scale ≤10
Övrig: Functional tests without clinical consequence for the patients therapy
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
Övrig: Functional tests without clinical consequence for the patients therapy
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
Övrig: Functional tests without clinical consequence for the patients therapy
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:

  1. Coronary revascularization (coronary artery bypass graft)
  2. Heart valve surgery
  3. Combined or complex heart surgery
Övrig: Functional tests without clinical consequence for the patients therapy
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
Övrig: Functional tests without clinical consequence for the patients therapy
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Nutritional status - basic demographics
Tidsram: at Study inclusion
Chart review
at Study inclusion
Nutritional Status - nutritional screening
Tidsram: 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)
Tidsram: 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
Tidsram: Study inclusion, up to 1 week
Waist and mid-arm circumferences
Study inclusion, up to 1 week
Differences of dosage of nutrition
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mortality Rate
Tidsram: up to 30 days after study inclusion
Mortality
up to 30 days after study inclusion
Length of stay - intensive care unit length of stay
Tidsram: 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
Tidsram: Hospital discharge, an average of 60 days
Hospital length of stay
Hospital discharge, an average of 60 days
Readmission - ICU readmission rate
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Hospital discharge, day 30 after study inclusion, up to 3 months
sepsis
Hospital discharge, day 30 after study inclusion, up to 3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

RWTH Aachen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 januari 2019

Primärt slutförande (Faktisk)

4 maj 2020

Avslutad studie (Faktisk)

4 maj 2020

Studieregistreringsdatum

Först inskickad

7 november 2019

Först inskickad som uppfyllde QC-kriterierna

25 november 2019

Första postat (Faktisk)

29 november 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 maj 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 maj 2022

Senast verifierad

1 maj 2022

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 19-001

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