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

Critical Illness Clinical Trial

— MALICUS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02564159
• Other study ID #: RC14_0424
• Status: Terminated
• Phase: N/A
• Start date: October 30, 2015
• Est. completion date: August 16, 2022

Study information

• Verified date: September 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 286
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Malnutrition

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-a), inflammatory proteins (C-Reactive Protein) and total oxidative stress (PATROL® test)	8 days
Secondary	3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline	NUTRIC-Score	8 days