- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03354767
The Role of Ischaemia-reperfusion Injury in the Pathogenesis of Muscle Wasting After Thoracic Aortic Surgery (RIMMAS)
Observational Study Into the Effect on Muscle Wasting and Multiple Organ Function of Ischaemia-reperfusion Injury After Major Aortic Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Some patients who are critically ill develop a syndrome of muscle weakness called Intensive Care Unit Acquired Paresis. This syndrome involves the development of severe muscle wasting and weakness and affects all skeletal muscles including the muscles which help one breathe. Muscle wasting and weakness whilst critically ill cause prolongation of mechanical ventilation, longer stays on the ICU, reduced mobility and prolonged rehabilitation in survivors. It has also been shown to increase the risk of death on ICU, due to an inability to wean patients from mechanical ventilation. Most patients recover; however in some, the effects last for many years and patients may not recover fully.
Although there is some understanding of why this syndrome develops, the molecular processes underlying the muscle wasting are not well understood. From the current scientific evidence, the investigators have identified a group or family of proteins believed to be important in the development of this condition, the activity of which are regulated by disease processes thought to lead to Intensive Care Unit Acquired Paresis (e.g. infection, inflammation, oxidative stress, immobility).
This research aims to investigate the role of these proteins in human tissue from patients who are at risk of Intensive Care Unit Acquired paresis. Even patients who do not go on to develop the full syndrome, in the early stages of ICU care, show some signs of muscle changes and loss of strength.
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- All adult (>18) patients undergoing major aortic or aortic valve surgery
Exclusion Criteria:
- Pre-existing cause for neuromuscular weakness or severe wasting (such as previous stroke, neuromuscular disease or malignancy)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Wasting patients
Patients with >10% loss of skeletal muscle one week after major aortic surgery
|
|
|
Non-wasting patients
Patients with <10% loss of skeletal muscle one week after major aortic surgery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Rectus Femoris muscle cross-sectional area (%)
Tidsramme: 7 days
|
Percentage change in cross sectional area of Rectus Femoris muscle (cm2) in the first post-operative week, from pre-operative measurement (measured the day before surgery), repeated on day 7 post-operatively
|
7 days
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjerte-kar-sygdomme
- Karsygdomme
- Sygdomme i nervesystemet
- Postoperative komplikationer
- Neurologiske manifestationer
- Muskuloskeletale sygdomme
- Neuromuskulære sygdomme
- Neuromuskulære manifestationer
- Patologiske Tilstande, Anatomiske
- Atrofi
- Iskæmi
- Muskelatrofi
- Reperfusionsskade
- Muskelsygdomme
Andre undersøgelses-id-numre
- ImperialC
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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