Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545825
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Prolonged and Chronic Critical Illness Induced by Brain Injury on Metabolic State Matched Case-control Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 344 to 420 cases per 100000 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
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 344 to 420 cases per 100000 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 prolongedchronic 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 prolongedCCI More than a third of patients after sepsis and in particular after abdominal sepsis develop prolongedCCI and according to Canadian authors this condition develops in one in six intensive care patients The overall prevalence is estimated at 344 cases per 100000 population and according to Japanese authors it reaches 420 cases per 100000 population this figure steadily increases with age reaching 1096 cases per 100000 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 ASs and TBIs 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 its 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
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 prolongedchronic 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 prolongedCCI More than a third of patients after sepsis and in particular after abdominal sepsis develop prolongedCCI and according to Canadian authors this condition develops in one in six intensive care patients The overall prevalence is estimated at 344 cases per 100000 population and according to Japanese authors it reaches 420 cases per 100000 population this figure steadily increases with age reaching 1096 cases per 100000 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 ASs and TBIs 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 its 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None