Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State
NCT Number: NCT06545825
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Brain Injuries|Stroke|Malnutrition|Critical Illness
Interventions: OTHER: Standard enteral nutrition
Sponsor: Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08-15
Completion Date: 2024-10-15

Summary:
Brain injuries, including acute stroke (AS) and traumatic brain injury (TBI), are prevalent pathologies with severe consequences. Cerebral infarction accounts for 65-85% of AS cases, while hemorrhagic stroke, though less common, has a higher mortality rate (30-50%) and limited recovery (10-20%). TBI is a significant medical and socioeconomic issue due to its high prevalence, severe consequences, and the high rates of temporary and permanent disability, particularly among young and working-age adults. The average mortality rate for severe TBI is 39%, with 60% facing unfavorable outcomes according to the Glasgow Outcome Scale.

High levels of permanent disability, a low percentage of patients returning to work, and long-term rehabilitation after brain injury impose a heavy economic and social burden. Severe brain damage often leads to chronic critical illness (CCI), a term introduced in 1985 to describe patients with prolonged ICU stays. CCI affects 6-10% of ICU patients, with an increasing prevalence. About 5-10% of those requiring mechanical ventilation develop CCI, with a significant number following sepsis. The prevalence of CCI is estimated at 34.4 to 42.0 cases per 100,000 people, increasing with age.

Malnutrition and the hypermetabolism-hypercatabolism syndrome are major complications in AS and TBI, leading to poor treatment outcomes and extended recovery periods. Effective rehabilitation is impossible without adequate nutritional support. Despite the universal metabolic response to different types of damage, specific metabolic disorders vary among different pathological conditions, both in macro- and micronutrient exchange.

Developing specialized enteral nutrition products tailored to specific conditions, like brain injury, is of great scientific and practical interest. To advance this development, comprehensive data on metabolic disorders in these patients is essential.

Primary Outcome Measures: Change from baseline in serum level of total protein, The serum level of total protein is measured in g/L. Normal values range from 65 to 85 g/L., From day 1 to day 20
Secondary Outcome Measures: Change from baseline in serum level of albumin, The serum level of albumin is measured in g/L. Normal values range from 35 to 52 g/L, From day 1 to day 20|Change from baseline in serum level of transferrin, The serum level of transferrin is measured in g/L. Normal values range from 2.0 to 3.6 g/L, From day 1 to day 20|Change from baseline in serum level of glucose, The serum level of glucose is measured in mmol/L. Normal values range from 3.3 to 6.5 mmol/L, From day 1 to day 20|Change from baseline in serum level of cholesterol, The serum level of cholesterol is measured in mmol/L. Normal values are less than 5.2 mmol/L, From day 1 to day 20|Change from baseline in serum level of very low density lipoprotein, The serum level of very low density lipoprotein is measured in mg/dL. Normal values range from 2 to 30 mg/dL, From day 1 to day 20|Change from baseline in serum level of low density lipoprotein, The serum level of low density lipoprotein is measured in mg/dL. Normal values are less than 100 mg/dL, From day 1 to day 20|Change from baseline in serum level of high density lipoprotein, The serum level of high density lipoprotein is measured in mg/dL. Normal values are greater than 60 mg/dL., From day 1 to day 20|Change from baseline in absolute lymphocyte count, absolute lymphocyte count is measured in lymphocytes per microliter. Normal values range from 1,000 to 4,800 lymphocytes per microliter., From day 1 to day 20