- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03019913
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients
Evaluation of Bedside Methods to Measure Muscularity in Critically Ill Patients: A Prospective Observational Study
Muscle wasting is a significant problem in critically ill patients, with reported losses of a half to three percent per day over the first ten days (for an average 70kg person this equates to 3 to 20kg of muscle loss). Low skeletal muscle mass at admission to the intensive care unit (ICU) and the loss of lean tissue have been associated with negative clinical outcomes, including increased incidence of infections, length of stay, mortality and muscle weakness. It is therefore crucial that technology is utilised to: 1) identify ICU patients with low muscularity on admission, 2) to help understand the factors impacting muscle loss and to 3) assess the effectiveness of interventions aimed at maintaining skeletal muscle mass in this population.
The measurement of lean body mass in patients admitted to the ICU is challenging however, due to the large fluid shifts that occur in this population and logistical issues in moving patients to specialised machinery for body composition analysis. Currently, there is no validated method for accurately assessing a patient's muscle mass at the bedside in the intensive care setting. It is therefore important to investigate the accuracy, feasibility and reliability of bedside methods such as subjective physical assessment of muscle mass, mid arm muscle circumference, ultrasound and bioimpedance analysis to assess muscularity in this population who are primarily bedbound. In order to do this, a critical comparison is required between these methods and muscularity assessed by a "reference" body composition method, such computed tomography (CT) image analysis. Briefly, quantification of skeletal muscle at the abdomen area utilising abdominal CT images has been shown to be highly representative of whole body skeletal muscle volume.
We wish to conduct a pilot, feasibility study (n= 50), which will recruit patients who have a CT scan (containing abdomen area), performed for clinical purposes. Our primary aim will be to investigate whether muscularity assessed with non-invasive bedside methods (ultrasound, bioimpedance analysis, SGA physical assessment, mid arm muscle circumference) are correlated with skeletal muscle mass quantified by a "reference method" (CT image analysis).
Panoramica dello studio
Descrizione dettagliata
Aim Our primary aim is to investigate whether muscularity assessed via bedside ultrasound is correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in the first few days of critical illness.
Our secondary aims are
- To investigate whether muscularity assessed via other bedside methods (bioimpedance spectroscopy, subjective physical assessment and mid arm muscle circumference) are correlated with a reference method for estimating whole body skeletal muscle mass (CT image analysis) in critically ill patients.
- To better understand the association between measured resting energy expenditure and muscularity in the critically ill.
- To observe changes in skeletal muscle mass (in a sub set of patients who have two CT scans) and the impact various factors, including energy and protein delivery has on these changes.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Have had a CT scan of the L3 vertebra performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
Exclusion Criteria:
- CT scan performed >48hrs ago
- Death is imminent or deemed highly likely in the next 96 hours
- Are known to be pregnant
- Treating clinician does not believe the study to be in the best interest of the patient
- It is not possible to image two or more muscle groups via ultrasound (i.e. due to trauma, burns, wounds)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Mean skeletal muscle mass measured by CT scan analysis at L3 area (cm2)
Lasso di tempo: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
|
Mean skeletal muscle mass measured by ultrasound (muscle thickness at each site, cm and rectus femoris CSA, cm2)
Lasso di tempo: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Fat free mass (kg), phase angle and impedance ratio measured by bioimpedance spectroscopy
Lasso di tempo: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Subjective assessment of muscle and fat wasting via SGA (normal, mild-moderate or severe)
Lasso di tempo: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Mid arm muscle circumference (cm)
Lasso di tempo: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Mean skeletal muscle mass measured by CT scan analysis at femoral area (cm2)
Lasso di tempo: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
|
Measured resting energy expenditure (kilojoules)
Lasso di tempo: <48 hours after CT scan containing L3 area
|
<48 hours after CT scan containing L3 area
|
|
Intramuscular, subcutaneous and visceral adipose tissue CSA at L3 area (cm2)
Lasso di tempo: CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
CT performed for clinical reasons ≤24 hours before or ≤72 hours after ICU admission
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Kate Lambell, MNutrDiet, La Trobe University and Alfred Health
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 523/16
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .
Prove cliniche su Observational cohort
-
IRCCS San RaffaeleAttivo, non reclutanteCarcinoma polmonare non a piccole cellule | Carenza di ricombinazione omologa | Inibitore PARP | EGFRItalia
-
Cairo UniversityNon ancora reclutamentoQualità del sonno, idoneità fisica e indice di massa corporea
-
Societat Catalana de Medicina Familiar i Comunitària...University of Barcelona; Fundacio d'Investigacio en Atencio Primaria Jordi Gol...Iscrizione su invitoArresto cardiaco | Cardiomiopatie | Ipertensione arteriosa | Fibrillazione atriale (FA) | Malattie cardiache valvolariSpagna
-
Izmir Democracy UniversityNon ancora reclutamento
-
Instituto de Investigación Biomédica de SalamancaCarlos III Health InstituteReclutamentoCondizione COVID persistenteSpagna
-
The Florey Institute of Neuroscience and Mental...The Alfred; Austin Health; University of Melbourne; University of Newcastle, Australia e altri collaboratoriReclutamentoIctus | Giovani adulti | Pazienti con ictus | Ictus; SequelaAustralia
-
London Health Sciences Centre Research Institute...Attivo, non reclutante
-
Shanghai Huicun Medical Technology Co., Ltd.Iscrizione su invitoCirrosi scompensataCina
-
Shanghai East HospitalNon ancora reclutamentoProgressione PSA | PSA
-
Union Hospital, Tongji Medical College, Huazhong...Non ancora reclutamento