Intensive Care Unit Syndrome Clinical Trial
— EcoSarcoOfficial title:
Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results
Verified date | September 2019 |
Source | Universidad Antonio de Nebrija |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Objectives: To characterize textural ultrasonographic biomarkers of the brachial biceps
musculature, wrist flexors, quadriceps and anterior tibial muscle that allow the recognition
of the muscular and functional status of patients undergoing programmed cardiovascular
surgery and relate them to mortality, hospital stay and functionality results after the
intervention.
Design: A first phase of cross-sectional observational study and a second phase of
longitudinal observational prospective study. Participants: Patients with programmed
cardiovascular surgery to aortic valve replacement Outcomes: Sociodemographic and
anthropometric variables, severity and clinical risk scales, disability, fragility and
quality of life scales, nutritional status and textural muscular biomarkers with
ultrasonography.
Expected results: strong association between ultrasound muscle biomarkers and ICU and
hospital stay, disability, fragility and quality of life after the surgery.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 1, 2019 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Waiting list patients with cardiovascular surgery scheduled for aortic valve refill Exclusion Criteria: - Urgency while waiting list - Patients with no evaluation by presurgery committee - Previous diagnosis of neuropathies, radiculopathy, polyneuropathy congenital or acquired or pathologies with muscular affectation |
Country | Name | City | State |
---|---|---|---|
Spain | Jose Rios-Diaz | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Antonio de Nebrija |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in muscle ultrasonography variation after surgery | Ultrasonography variation is a measure of the degree of heterogeneity of a ultrasonographic image which provides information on changes in tissue structure (muscles). | 6 months | |
Primary | Changes in muscle echointensity after surgery | Echointensity is the average of echogenicity of a ultrasonographic image which provides information on changes in tissue structure | 6 months | |
Primary | Changes in muscle texture after surgery | Muscle texture can be characterized by advanced image analysis algorithms such grey level co-occurrence matrices. In this case 5 textural parameters (uniformity, contrast, homogeneity, correlation and entropy) used together are used to characterize the tissue. | 6 months |
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