Malnutrition Screening by Muscle Ultrasound in Patients Requiring Mechanical Ventilation in Intensive Care Unit

NCT ID: NCT02564159

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-30
• Study Completion Date: 2022-08-16

Brief Summary

Malnutrition is a major risk factor for morbidity and mortality of patients managed in intensive care unit. Early recognition and treatment of adult malnutrition are recommended in acute care settings especially for patients requiring mechanical ventilation. Biochemical indicators like serum concentrations of albumin and prealbumin (transthyretin) have a tradition of being used as markers of nutritional status but remains influenced by nonnutritional factors. A recent assessment of quadriceps muscle diameter with ultrasound method has gained interest for screening and follow-up of muscle weakness at the bedside in critically ill patients. In this light, the MALICUS project aims to investigate the validity of ultrasound as measurement tool for assessing malnutrition acquired in intensive care unit.

Skeletal muscle is central to cytokine regulation and it contributes 85% of total body glucose clearance. Some research findings suggest that muscle wasting is a smoldering inflammatory state partially driven by cytokines and oxidative stress but these conclusions need to be investigated in context of critically ill patients and perioperative settings.

The investigators search to determine impact of inflammatory biomarkers (IL-1, IL-6 and TNF-α) and oxidative stress (evaluated by quantifying the global anti-oxidative defenses in patient with an original method (Patrol® test) based on the use of excited molecular oxygen (singlet oxygen) as a source of ROS on erosion of lean body mass measure with quadriceps muscle ultrasound. Consequently, in an ancillary study of the MALICUS project, the investigators wish to investigate interaction between acute inflammation and muscle wasting.

Conditions

Malnutrition; Critical Illness

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

High-risk patient for malnutrition acquired in ICU

Patients admitted in ICU and treated with mechanical ventilation with expected duration of 48 hours or more

Group Type: EXPERIMENTAL

Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

Intervention Type: OTHER

• Evaluation of quadriceps diameter on the anterior aspect of the thigh using the mid-distance between the anterior superior iliac spine and the upper pole of the patella ;
• Biospecimen collection: Blood samples (prealbumin levels, C-reactive protein, Interleukin-1, Interleukin-6, TNF-alpha and PATROL test™)collection of albumin and prealbumin levels

Controls patients: Elective surgery

Controls patients: Elective surgery (neurosurgery, thoracic surgery, vascular surgery)

• Patients admitted in a post-operative care unit of the university hospital of Nantes after elective surgery with expected duration ICU length of stay < 48 hours

Group Type: OTHER

Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

Intervention Type: OTHER

• Evaluation of quadriceps diameter on the anterior aspect of the thigh using the mid-distance between the anterior superior iliac spine and the upper pole of the patella ;
• Biospecimen collection: Blood samples (prealbumin levels, C-reactive protein, Interleukin-1, Interleukin-6, TNF-alpha and PATROL test™)collection of albumin and prealbumin levels

Interventions

Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

• Evaluation of quadriceps diameter on the anterior aspect of the thigh using the mid-distance between the anterior superior iliac spine and the upper pole of the patella ;
• Biospecimen collection: Blood samples (prealbumin levels, C-reactive protein, Interleukin-1, Interleukin-6, TNF-alpha and PATROL test™)collection of albumin and prealbumin levels

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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1. MALICUS Study

• Patient requiring invasive mechanical ventilation

• Expected duration of ventilation longer than 48 hours

• Age > 18 years
• Subjects affiliated with an appropriate social security system

• Invasive mechanical ventilation started for more than 48 hours

• Patient severely malnourished at baseline (at least one of the following criteria)
• Prealbuminemia < 0,11 g/L
• BMI ≤ 18,5 (or ≤ 22 beyond 70 years)
• Unintentional weight loss > 5% in the previous month or > 10% in the last 6 months - Glomerular nephropathy history/nephrotic syndrome, chronic renal failure (MDRD < 30 ml/min), liver cirrhosis or exudative gastro-enteropathy - Glucocorticoid (> 10 mg / day of prednisone equivalent ) long-term therapy ( > 1 month) - Impossible ultrasound measure of anterolateral diameter for the two quadriceps muscles

• Neuromuscular disease that can cause muscle atrophy at a lower limb, without any support in the ICU

2. Control group - BIOBANK-MALICUS

• Elective surgery requiring an ICU stay (neurosurgery, vascular surgery, thoracic surgery)
• Expected duration of ventilation shorter than 48 hours

• Elective surgery with cardiopulmonary bypass

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand ROZEC, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

RC14_0424

Identifier Type: -

Identifier Source: org_study_id