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

NCT06545825 | Completed DMC

• 1 other identifier: PRIME-Met
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Brain Injuries; Stroke; Malnutrition; Prolonged critical illness; Chronic critical illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline in serum level of albumin

  From day 1 to day 20

• Change from baseline in serum level of transferrin

  From day 1 to day 20

• Change from baseline in serum level of glucose

  From day 1 to day 20

• Change from baseline in serum level of cholesterol

  From day 1 to day 20

• Change from baseline in serum level of very low density lipoprotein

  From day 1 to day 20

Study Arms (1)

Standard enteral nutrition

Patients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition

Other: Standard enteral nutrition

Interventions

Standard enteral nutrition OTHER

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

Standard enteral nutrition

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition

You may qualify if:

• 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

You may not qualify if:

• Diabetes mellitus
• Acute kidney injury
• Acute liver failure
• Shock of any etiology
• Presence of a cardiac implantable electronic device or neurostimulator
• Presence of a tracheoesophageal fistula
• Positive end expiratory pressure \> 12 mbar
• Patients previously included in this trial

Sponsors & Collaborators

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

Study Sites (1)

Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

Moscow, Moscow Oblast, 107031, Russia

Location

MeSH Terms

Conditions

Brain Injuries; Stroke; Malnutrition; Critical Illness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Shestopalov, PhD

  Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: September 9, 2024
• Primary Completion: October 24, 2024
• Study Completion: November 15, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)