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

Ultrasound Measurement of the Quadriceps Muscle Diameter for the Detection and the Follow-up of Malnutrition in Patients Receiving Mechanical Ventilation in Intensive Care Unit

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.

Study Overview

• Status: Terminated
• Conditions: Critical Illness; Malnutrition
• Intervention / Treatment: Other: Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

• Study Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Study Population

Subjects will be enrolled from 2 venues:

1. Adults ICU patients (> 18 years) requiring period of mechanical ventilation. Subjects affiliated with an appropriate social security system
2. Adults patients admit requiring ICU length of stay < 48h after eligible surgery

1. MALICUS Study

   Inclusion Criteria:

   - Patient requiring invasive mechanical ventilation

   - Expected duration of ventilation longer than 48 hours

   - Age > 18 years

   • Subjects affiliated with an appropriate social security system

   Non inclusion Criteria:

   - 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

Inclusion criteria:

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

Non inclusion criteria:

• Elective surgery with cardiopulmonary bypass

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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
Other: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of ultrasound measurement of the quadriceps muscle anteroposterior diameter for the diagnosis of malnutrition in patients requiring mechanical ventilatory support in ICU	Anteroposterior diameter of the quadriceps muscle (mid-thigh distance between the anterior superior iliac spine and the upper pole of the patella) will be compared with biochemical method (prealbumin levels). Patients will be classified as true positive, true negative, false positive or false negative relative to the gold standard (biochemical method). The sensitivity and the specificity of ultrasound method to detect malnutrition will be calculated with their 95% confidence interval.	8 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and Interleukin 6 level	Biospecimen collection (serum) Blood serum for biological specimen of pro-inflammatory cytokines (IL-1, IL-6 and TNF-α), inflammatory proteins (C-Reactive Protein) and total oxidative stress (PATROL® test)	8 days
3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline	NUTRIC-Score	8 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Bertrand ROZEC, Pr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2015
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): August 16, 2022

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: September 29, 2015
• First Posted (Estimate): September 30, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; mechanical ventilation; nutrition; albumin; malnutrition; muscle ultrasound; prealbumin
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Nutrition Disorders; Critical Illness; Malnutrition
• Other Study ID Numbers: RC14_0424