Brain InjuriesNCT06545825
Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State
An observational study of Brain Injuries and Stroke, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Brain Injuries, Stroke, Malnutrition
- What is being tested?
- Standard enteral nutrition
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 9 Sep 2024to 15 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
Moscow, Moscow Oblast, 107031
About this study
Official title: Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State: Matched Case-control Study
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.
Read more
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.
Read the detailed description
Brain injury is a common pathology and is most often represented by acute stroke (AS) and traumatic brain injury (TBI). 65-85% of diagnosed acute stroke is cerebral infarction. Hemorrhagic stroke is less common, but its mortality is higher. Mortality in hemorrhagic stroke ranges from 30 to 50%, and recovery of functional activity is only in 10-20%. TBI remains a serious medical and socioeconomic problem because of prevalence and severity of consequences, high levels of temporary and permanent disability, and high mortality rates. TBI is the most common death reason and disability among young and adult people, as it is the most active part of the population in work and social relations. The average weighted mortality rate for severe TBI is 39%, and for an unfavorable outcome according to the Glasgow Outcome Scale (GOS) - 60%. TBI ranks first in mortality and disability among the population under 44 years of age.
The high level of permanent disability, low percentage of patients returning to work, long-term rehabilitation after brain injury is a heavy economic and social burden. Severe brain damage can also lead to the development of prolonged/chronic critical illness.
In 1985, scientists first described the characteristics of patients who spent a long time in the intensive care unit (ICU) and introduced the term "chronically critically ill". Then many authors introduced the terms prolonged critical illness, protracted critical illness, which meant a long-term or prolonged critical condition. Of the total number of ICU patients, 6 to 10% are patients with chronic critical illness syndrome (CCI). It should be noted that the proportion of this category of patients in ICUs has tended to increase in recent years. It is estimated that 5-10% of patients who require mechanical ventilation as part of their initial illness will go on to develop prolonged/CCI. More than a third of patients after sepsis, and in particular after abdominal sepsis, develop prolonged/CCI, and according to Canadian authors, this condition develops in one in six intensive care patients. The overall prevalence is estimated at 34.4 cases per 100,000 population, and according to Japanese authors it reaches 42.0 cases per 100,000 population (this figure steadily increases with age, reaching 109.6 cases per 100,000 population over 85 years of age).
Malnutrition and metabolic response to stress as the form of hypermetabolism-hypercatabolism syndrome are among the leading complications and one of the main links in AS's and TBI's pathogenesis. These determine the unfavorable course and results of treatment of this category of patients. In this time that syndrome is considered both as an independent cause of death and as a factor provoking a large number of complications. Malnutrition significantly extends the treatment period and also affects the recovery process. So it's impossible to perform effective rehabilitation without nutritional support.
Although the metabolic response is universal to different types of damage, many studies indicate that there are certain features of metabolic disorders in different pathological conditions. This is true for both macro- and micronutrient exchange. Therefore, the development of specialized enteral nutrition products with a metabolic focus on a specific pathological condition, in particular brain injury, is of great scientific and practical interest.
Thus, in order to move on to the development of such products, it is necessary to obtain data on the full picture of metabolic disorders in this category of patients.
- Conditions
- Brain Injuries, Stroke, Malnutrition, Critical Illness
- Being tested
- Standard enteral nutrition
- Keywords
- Brain Injuries, Stroke, Malnutrition, Prolonged critical illness, Chronic critical illness
- Medical subject headings
- Brain Injuries, Stroke, Malnutrition, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard enteral nutritionOther
Enteral nutrition will be given with standard isocaloric mixtures. Mixture volume calculation will be performed after indirect calorimetry, adjusted for daily nitrogen loss.
| Study group | Role | What they receive |
|---|---|---|
| Standard enteral nutrition | Patients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition Receives: Other: Standard enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day 1 to day 20
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: From day 1 to day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start9 Sep 2024
- Primary completion24 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Shestopalov, PhD, Principal investigator, Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545825
- Sponsor's protocol ID
- PRIME-Met
- Status last verified
- Nov 2024
- First submitted
- 6 Aug 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State: Matched Case-control Study
- ClinicalTrials.gov ID
- NCT06545825
- Acronym / sponsor ID
- PRIME-Met
- Conditions
- Brain Injuries, Stroke, Malnutrition, Critical Illness
- Keywords
- Brain Injuries, Stroke, Malnutrition, Prolonged critical illness, Chronic critical illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal Research and Clinical Centre of Intensive Care Medicine and RehabilitologyUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Brain injury is a common pathology and is most often represented by acute stroke (AS) and traumatic brain injury (TBI). 65-85% of diagnosed acute stroke is cerebral infarction. Hemorrhagic stroke is less common, but its mortality is higher. Mortality in hemorrhagic stroke ranges from 30 to 50%, and recovery of functional activity is only in 10-20%. TBI remains a serious medical and socioeconomic problem because of prevalence and severity of consequences, high levels of temporary and permanent disability, and high mortality rates. TBI is the most common death reason and disability among young and adult people, as it is the most active part of the population in work and social relations. The average weighted mortality rate for severe TBI is 39%, and for an unfavorable outcome according to the Glasgow Outcome Scale (GOS) - 60%. TBI ranks first in mortality and disability among the population under 44 years of age.
The high level of permanent disability, low percentage of patients returning to work, long-term rehabilitation after brain injury is a heavy economic and social burden. Severe brain damage can also lead to the development of prolonged/chronic critical illness.
In 1985, scientists first described the characteristics of patients who spent a long time in the intensive care unit (ICU) and introduced the term "chronically critically ill". Then many authors introduced the terms prolonged critical illness, protracted critical illness, which meant a long-term or prolonged critical condition. Of the total number of ICU patients, 6 to 10% are patients with chronic critical illness syndrome (CCI). It should be noted that the proportion of this category of patients in ICUs has tended to increase in recent years. It is estimated that 5-10% of patients who require mechanical ventilation as part of their initial illness will go on to develop prolonged/CCI. More than a third of patients after sepsis, and in particular after abdominal sepsis, develop prolonged/CCI, and according to Canadian authors, this condition develops in one in six intensive care patients. The overall prevalence is estimated at 34.4 cases per 100,000 population, and according to Japanese authors it reaches 42.0 cases per 100,000 population (this figure steadily increases with age, reaching 109.6 cases per 100,000 population over 85 years of age).
Malnutrition and metabolic response to stress as the form of hypermetabolism-hypercatabolism syndrome are among the leading complications and one of the main links in AS's and TBI's pathogenesis. These determine the unfavorable course and results of treatment of this category of patients. In this time that syndrome is considered both as an independent cause of death and as a factor provoking a large number of complications. Malnutrition significantly extends the treatment period and also affects the recovery process. So it's impossible to perform effective rehabilitation without nutritional support.
Although the metabolic response is universal to different types of damage, many studies indicate that there are certain features of metabolic disorders in different pathological conditions. This is true for both macro- and micronutrient exchange. Therefore, the development of specialized enteral nutrition products with a metabolic focus on a specific pathological condition, in particular brain injury, is of great scientific and practical interest.
Thus, in order to move on to the development of such products, it is necessary to obtain data on the full picture of metabolic disorders in this category of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard enteral nutrition | – | Other: Standard enteral nutritionPatients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prolonged or chronic critical illness and brain injury receiving standard enteral nutrition
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Diabetes mellitus
- Acute kidney injury
- Acute liver failure
- Shock of any etiology
- Presence of a cardiac implantable electronic device or neurostimulator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard enteral nutritionEnteral nutrition will be given with standard isocaloric mixtures. Mixture volume calculation will be performed after indirect calorimetry, adjusted for daily nitrogen loss. | Other | Standard enteral nutrition |
Primary outcome
Change from baseline in serum level of total protein
Time frame: From day 1 to day 20
The serum level of total protein is measured in g/L. Normal values range from 65 to 85 g/L.
8 secondary outcomes
Change from baseline in serum level of albumin
Time frame: From day 1 to day 20
Change from baseline in serum level of transferrin
Time frame: From day 1 to day 20
Change from baseline in serum level of glucose
Time frame: From day 1 to day 20
Change from baseline in serum level of cholesterol
Time frame: From day 1 to day 20
Change from baseline in serum level of very low density lipoprotein
Time frame: From day 1 to day 20
Change from baseline in serum level of low density lipoprotein
Time frame: From day 1 to day 20
Change from baseline in serum level of high density lipoprotein
Time frame: From day 1 to day 20
Change from baseline in absolute lymphocyte count
Time frame: From day 1 to day 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Shestopalov, PhD principal investigator
Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries and Stroke, run by Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in serum level of total protein (time frame: From day 1 to day 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.