The BIA and MUS in the Detection of Nutritional Status in Critically Ill Patients

NCT03924232 | Completed DMC

• 1 other identifier: BUS
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Critically ill patients are characterized by wide variations in their carbohydrate, lipid, and protein metabolism. Such variations can lead to increase in their energy requirement with accelerated protein catabolism and ultimately alterations of their immune and gastrointestinal systems, and in a variable frame time, it lead to a disruption of muscular function that increased the ICU and hospital stay and mortality. There are multiple methods to conduct these measurements. However, the accuracy of these measures could be very scares. Skeletal muscle wasting in the critically ill is often masked by fluid retention. For these reasons, in the last few decades, several different tools have been developed to integrate the clinical and biochemical nutritional evaluations. Among these, the bioimpedance analysis (BIA) and the muscular ultrasonography (MU) seem to be promising tools for this purpose. The aim of this project is to compare and integrate the data collected by BIA and MU and the routinely clinical used parameters of nutrition to define the nutritional status of critically ill patients. The data from these tools and the biochemical and anthropometric nutritional data (including the nutritional support) will be collected at the admission in ICU and followed up within the first week of ICU stay.

Conditions

MUSCULAR AQUIRED WEAKNESS; Bioelectrical Impedance Analysis; Muscular Ultrasound

Outcome Measures

Primary Outcomes (1)

• phase angle (PA)

  variations of phase angle detected by BIVA and comparison within one week of ICU stay

  one week

Secondary Outcomes (2)

• peripheral muscular ultrasound

  one week

• Diaphragm ultrasound

  one week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients

You may qualify if:

• All patients aged 18 or older and with a recent (\<48h) ICU entry requiring mechanical ventilation for at least 3 days will be considered for enrolment

You may not qualify if:

• not intubated patients
• patients with an ICU prevision of stay less than 3 days

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo

Milan, MI, 20142, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 23, 2019
• Study Start: October 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

IT (1)