- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03269825
The Use of Computed Tomography (CT) to Measure Skeletal Muscle Quantity and Quality in Patients Receiving ECMO
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The use of veno-venous extra-corporeal membrane oxygenation (VV-ECMO) for severe respiratory failure - mainly hypoxaemia - has increased over recent years. Similar to the general population in the Intensive Care Unit (ICU), these patients become deconditioned, severely weak (ICU acquired weakness- ICUAW) and require prolonged rehabilitation after disconnection from VV-ECMO. However, data regarding the magnitude of muscle wasting and recovery in this specific group is lacking.
Both poor muscle quantity and quality have been found to be a predictor or poor outcome. As all patients receiving VV-ECMO at our hospital will get an initial CT scan of their chest, abdomen and pelvis, these CT scans will be used to measure muscle quantity and quality of different muscle groups of the abdomen at admission and then using any follow-up CT scan performed within 10 days. In addition, the relationship between the loss of muscle over the course of VV-ECMO and perceived recovery of renal function at ICU discharge will be investigated.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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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:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and had one or more CT scans of their abdomen
Exclusion Criteria:
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO and did not have one or more CT scans of their abdomen
- Critically ill patients with Severe Respiratory Failure who required VV-ECMO who have a poor quality CT scan not analysable by the software
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
All cause mortality
Lasso di tempo: On ECMO (expected to be about 10 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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On ECMO (expected to be about 10 days)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Length of ECMO duration
Lasso di tempo: The total duration on ECMO (expected to be an average of 10 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration on ECMO (expected to be an average of 10 days)
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Length of ICU admission
Lasso di tempo: The total duration of ICU admission (expected to be around 2 weeks)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration of ICU admission (expected to be around 2 weeks)
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Length of hospital stay
Lasso di tempo: The total duration of hospital admission (expected to be around 28 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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The total duration of hospital admission (expected to be around 28 days)
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Length of ventilation
Lasso di tempo: Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Total duration of mechanical ventilation during intensive care unit stay (expected to be around 10 days)
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Discharge destination
Lasso di tempo: After discharge from hospital (expected to be around 28 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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After discharge from hospital (expected to be around 28 days)
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Sequential changes in the muscle quantity over time
Lasso di tempo: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
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The total duration of ECMO (expected to be around 10 days)
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Sequential changes in muscle quality over time
Lasso di tempo: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quality measured from CT slice of the third lumbar region.
|
The total duration of ECMO (expected to be around 10 days)
|
Relationship between muscle loss and total nutrition received
Lasso di tempo: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
|
The total duration of ECMO (expected to be around 10 days)
|
Relationship between muscle loss and rehabilitation goals met
Lasso di tempo: The total duration of ECMO (expected to be around 10 days)
|
Using total muscle quantity measured from CT slice of the third lumbar region.
|
The total duration of ECMO (expected to be around 10 days)
|
All cause mortality
Lasso di tempo: Intensive Care Unit Stay (expected to be about 2 weeks)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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Intensive Care Unit Stay (expected to be about 2 weeks)
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All cause mortality
Lasso di tempo: 6 months post-ICU discharge
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
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6 months post-ICU discharge
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All cause mortality
Lasso di tempo: Hospital discharge (expected to be about 28 days)
|
Using total muscle quantity and quality measured from CT slice of the third lumbar region.
|
Hospital discharge (expected to be about 28 days)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Danielle E Bear, MRes, Guy's and St Thomas' NHS Foundation Trust
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Inizio studio (Effettivo)
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 (Effettivo)
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
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 17/WA/0166
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