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Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State

NCT06545825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

  • Brain Injuries
  • Stroke
  • Malnutrition
  • Critical Illness

Interventions

OTHER

Standard enteral nutrition

Enteral nutrition will be given with standard isocaloric mixtures. Mixture volume calculation will be performed after indirect calorimetry, adjusted for daily nitrogen loss.

Sponsors & Collaborators

  • Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

    lead OTHER

Principal Investigators

  • Alexander Shestopalov, PhD · Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2024-10-24
Completion
2024-11-15

Countries

  • Russia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06545825 on ClinicalTrials.gov