Fragility and Programmed Cardiovascular Surgery (EcoSarco)

Intensive Care Unit Syndrome Clinical Trial

— EcoSarco  

Official title:

Fragility and Programmed Cardiovascular Surgery: Development of Muscle Ultrasonographic Biomarkers of Sarcopenia and Post-surgical Results

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110509
• Other study ID #: ECOSARCO_CARDIO v0.2
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: September 2019
• Source: Universidad Antonio de Nebrija
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fragility
• Intensive Care Unit Syndrome

Locations

Country	Name	City	State
Spain	Jose Rios-Diaz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Antonio de Nebrija

Country where clinical trial is conducted

Spain, 

Outcome

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