Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

25. Mai 2022 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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
Sonstiges: 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
Sonstiges: 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
Sonstiges: 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
Sonstiges: 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
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

RWTH Aachen University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

4. Januar 2019

Primärer Abschluss (Tatsächlich)

4. Mai 2020

Studienabschluss (Tatsächlich)

4. Mai 2020

Studienanmeldedaten

Zuerst eingereicht

7. November 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. November 2019

Zuerst gepostet (Tatsächlich)

29. November 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Mai 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Mai 2022

Zuletzt verifiziert

1. Mai 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 19-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Herzchirurgische Patienten

Klinische Studien zur Functional tests without clinical consequence for the patients therapy

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Gabon

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren