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

Not Applicable

Terminated

• Conditions: Critical Illness; Malnutrition
• Interventions: Other: Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels

• Registration Number: NCT02564159
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-29
• Study First Posted: 2015-09-30
• Study Start: 2015-10-30
• Primary Completion: 2022-08-16
• Study Completion: 2022-08-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 286

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Controls patients: Elective surgery	Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels	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
High-risk patient for malnutrition acquired in ICU	Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels	Patients admitted in ICU and treated with mechanical ventilation with expected duration of 48 hours or more

Primary Outcome Measures

Name	Time	Method
Sensitivity of ultrasound measurement of the quadriceps muscle anteroposterior diameter for the diagnosis of malnutrition in patients requiring mechanical ventilatory support in ICU	8 days	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.

Secondary Outcome Measures

Name	Time	Method
3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline	8 days	NUTRIC-Score
Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and Interleukin 6 level	8 days	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)

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France