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

25 maggio 2022 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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)

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: Coorte
  • Prospettive temporali: Prospettiva

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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
Altro: 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
Altro: 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
Altro: 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
Altro: 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
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Nutritional status - basic demographics
Lasso di tempo: at Study inclusion
Chart review
at Study inclusion
Nutritional Status - nutritional screening
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Study inclusion, up to 1 week
Waist and mid-arm circumferences
Study inclusion, up to 1 week
Differences of dosage of nutrition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mortality Rate
Lasso di tempo: up to 30 days after study inclusion
Mortality
up to 30 days after study inclusion
Length of stay - intensive care unit length of stay
Lasso di tempo: 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
Lasso di tempo: Hospital discharge, an average of 60 days
Hospital length of stay
Hospital discharge, an average of 60 days
Readmission - ICU readmission rate
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Hospital discharge, day 30 after study inclusion, up to 3 months
sepsis
Hospital discharge, day 30 after study inclusion, up to 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

RWTH Aachen University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 gennaio 2019

Completamento primario (Effettivo)

4 maggio 2020

Completamento dello studio (Effettivo)

4 maggio 2020

Date di iscrizione allo studio

Primo inviato

7 novembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

25 novembre 2019

Primo Inserito (Effettivo)

29 novembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 maggio 2022

Ultimo verificato

1 maggio 2022

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 19-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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