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NCT06545825Completed

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

Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State: Matched Case-control Study

Source: ClinicalTrials.gov · Last updated 29 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
30 (actual)
First submitted
6 Aug 2024
Start date
9 Sept 2024
Primary completion date
24 Oct 2024
Lead sponsor
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Diseases
Stroke
NCT number
NCT06545825

What you commit to

  • Study type: Observational
  • Participants enrolled: 30
  • From 9 Sept 2024 to the primary completion date, 24 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients previously included in this trial

Other illness

  • Diabetes mellitus
  • Acute liver failure
  • Presence of a cardiac implantable electronic device or neurostimulator
  • Presence of a tracheoesophageal fistula

Other

  • Acute kidney injury
  • Shock of any etiology
  • Positive end expiratory pressure \> 12 mbar

Who the study is looking for

  • Patient's age is between 18 and 74
  • Stay in the intensive care unit \>5 days from the time of injury
  • Presence of brain injury or stroke
  • Receiving enteral nutrition
  • Informed voluntary consent of the patient to participate in the study, or a decision of the medical council to include the patient in the study

Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.