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

NCT02564159 | Terminated

• 1 other identifier: RC14_0424
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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

Keywords

malnutrition; muscle ultrasound; intensive care unit; mechanical ventilation; albumin; prealbumin; nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and Interleukin 6 level

  8 days

• 3. Comparing measurement of quadriceps muscle diameter measure by ultrasound of the thigh and NUTRIC-Score at baseline

  8 days

Study Arms (2)

High-risk patient for malnutrition acquired in ICU

EXPERIMENTAL

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

Controls patients: Elective surgery

OTHER

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

Interventions

Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels 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; High-risk patient for malnutrition acquired in ICU

Eligibility Criteria

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

You may qualify if:

• \- 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Malnutrition; Critical Illness

Interventions

High-Energy Shock Waves; Albumins

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Bertrand ROZEC, Pr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: September 30, 2015
• Study Start: October 30, 2015
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

FR (1)