Fragility and Programmed Cardiovascular Surgery (EcoSarco)

Completed

• Conditions: Intensive Care Unit Syndrome; Fragility

• Registration Number: NCT04110509
• Lead Sponsor: Universidad Antonio de Nebrija

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-01-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in muscle ultrasonography variation after surgery	6 months	Ultrasonography variation is a measure of the degree of heterogeneity of a ultrasonographic image which provides information on changes in tissue structure (muscles).
Changes in muscle echointensity after surgery	6 months	Echointensity is the average of echogenicity of a ultrasonographic image which provides information on changes in tissue structure
Changes in muscle texture after surgery	6 months	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.

Trial Locations

Locations (1)

Jose Rios-Diaz; 🇪🇸 Madrid, Spain