Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651803
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2020-11-26
Brief Title:
Outcome in Traumatic Brain Injury Elderly Patients
Sponsor:
Association pour la Recherche en Aanesthésie Réanimation Digestive
Organization:
Association pour la Recherche en Aanesthésie Réanimation Digestive
Study Overview
Official Title:
Factors Associated With Unfavorable Outcome in Traumatic Brain Injury Elderly Patients A Retrospective Multicenter Study
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients suffering from traumatic brain injury TBI the studys purpose was to determinate factors associated with mortality and poor functional outcome at 3 months in patients aged 65 hospitalized in ICU and to compare outcome at 3 months between younger patients 18-64 years vs older patients 65 years
Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37 of all injury-related death in Europe This was particularly true for patients 65 years old and in the most severe caseGlasgow coma score 8 with mortality rates between 31 to 51 Over time epidemiological patterns of TBI are changing Indeed in high-income countries overall incidence is steadily decreasing but increasing in elderly population with falls becoming the leading cause of TBI In parallel the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 9 million persons aged 65 years in the global population and that this proportion is projected to rise further to 16 in 2050 Accordingly we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades
In a study performed in three neuro-intensive care unit ICUs from 1997 to 2007 6-month mortality in patients aged of 70-79 and 80 years was 59 and 79 respectively In severe elderly 65 years TBI patients admitted in ICU hospital and 6-month mortality was 646 and 729 respectively Beyond mortality TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities frequent use of oral anticoagulants andor antiplatelet andor previous brain disorders In patients hospitalized in ICU age 59 years was the strongest parameter associated with an unfavorable outcome including death vegetative state and severe disability at 6 month Moreover TBI elderly patients 65 years had worse functional outcome at discharge than younger patients Identifying elderly patients who may benefit from ICU remained challenging since there is no consensual guideline of triage Traumatic brain-injured patients are particularly concerned by this issue Nevertheless few data are available related to outcome in elderly TBI patients requiring ICU
Traumatic brain injury is a common cause of hospitalization for trauma and accounting for roughly 37 of all injury-related death in Europe This was particularly true for patients 65 years old and in the most severe caseGlasgow coma score 8 with mortality rates between 31 to 51 Over time epidemiological patterns of TBI are changing Indeed in high-income countries overall incidence is steadily decreasing but increasing in elderly population with falls becoming the leading cause of TBI In parallel the World Population Ageing 2019 report of the Population Division of the United Nations Department of Economic and Social Affairs reported 703 9 million persons aged 65 years in the global population and that this proportion is projected to rise further to 16 in 2050 Accordingly we could expect that TBI in elderly would be increasing and could explain why mortality did not improved in the latest decades
In a study performed in three neuro-intensive care unit ICUs from 1997 to 2007 6-month mortality in patients aged of 70-79 and 80 years was 59 and 79 respectively In severe elderly 65 years TBI patients admitted in ICU hospital and 6-month mortality was 646 and 729 respectively Beyond mortality TBI can lead to poor functional neurologic outcome and elderly patients are more prone to survive with disabilities according to a higher rate of comorbidities frequent use of oral anticoagulants andor antiplatelet andor previous brain disorders In patients hospitalized in ICU age 59 years was the strongest parameter associated with an unfavorable outcome including death vegetative state and severe disability at 6 month Moreover TBI elderly patients 65 years had worse functional outcome at discharge than younger patients Identifying elderly patients who may benefit from ICU remained challenging since there is no consensual guideline of triage Traumatic brain-injured patients are particularly concerned by this issue Nevertheless few data are available related to outcome in elderly TBI patients requiring ICU
Detailed Description:
The investigators conducted a multicentre retrospective observational study from April 2013 to February 2019 in the surgical ICUs of 5 level 1 Trauma centers in France The investigators collected data from the regional intensive care network of the great west of france AtlanRéa database The AtlanRéa database registers prospectively and consecutively numerous informations about brain injury and trauma patients hospitalized in ICUs in order to provide epidemiologic informations for this population Data were collected by clinical research assistants in each participating ICU using an electronic case report form The investigators assessed data regarding outcomes after discharge from ICUs through phone interview led by dedicated clinical research assistants
The following data were entered in the database Age gender and body mass index previous medical history and more specifically the presence of cardiac insufficiency chronic renal failure defined as an estimated glomerular filtration rate less than 60 mlmin173 m-1 chronic respiratory illness neurologic background diabetes neoplasia history previous TBI active smoking and chronic alcoholism Mechanism of injury domestic accident road traffic crash fall from heights or others The Glasgow Coma Score GCS score determinates in the prehospital setting or at admission at hospital before intubation andor sedation and the presence of at least one nonreactive and dilated pupil at the initial management Severity of illness according to the Simplified Acute Physiology Score II SAPS II the Sequential Organ Failure Assessment SOFA score and the Injury Severity Score ISS The investigators also specified the severity of TBI by the abbreviated Injury Score AIS and reported the associated injuries from 5 territories face chest abdomen extremity including pelvis and external Initial CT-scan was classified according to the Marshall classification in six categories Diffuse injury I II III IV evacuated mass V and non-evacuated mass lesion VI
The following data during the patients hospitalization are also entered in the database use of an intracranial pressure ICP catheter occurrence of intracranial hypertension defined as an ICP above 20 mmHg in absence of confounding factors and use of barbiturates andor osmotherapy decompressive craniectomy and other neurosurgical procedure The occurrence of intercurrent events occurring during ICU stay including infections Acute Respiratory Distress Syndrome ARDS need of vasopressor drugs acute renal failure thrombophlebitis pulmonary embolism hemorrhage infection and tracheostomy The investigators specified the need for intubation and durations of mechanical ventilation central venous catheterism and vasopressor The investigators also recorded the decision in ICU to withdraw or withhold life support
The length of stay in ICU ICU and 3-month mortalities and patient outcome were assessed using the Glasgow Outcome Scale Extended GOSE score at 3 months The investigators dichotomized the GOSE score between the four lower values corresponding to unfavorable outcome- GOSE 1 to 4 and the four upper values corresponding to favorable outcome- GOSE 5 to 8
Statistical Analysis All statistical analysis will be performed using R software 331 package pROC and SAS 91 Statistical Software SAS Institute Cary NC USA For quantitative continuous variables position and dispersion parameters mean standard deviation median interquartile range will be calculated For qualitative variables proportion rates will be calculated For groups comparison we used independent-samples t-tests for normally distributed continuous variables and Mann-Whitney U-tests for non-normally distributed continuous variables Χ² tests will be performed for categorical variables To build the model for multivariate analysis the investigators selected among the variables with a p 020 according to the univariate analysis The investigators performed logistic regression model to identify factors associated with in-ICU mortality and dichotomized GOSE score at 3 months The Odds Ratios ORs and 95 confidence intervals CI will be calculated For continuous variables diagnosis of log linear behavior was established and if not confirmed the variable will be divided into categories and treated as categorical variables Models fit will be assessed by checking residual plots and Cooks distance The calibration of the model will be tested by Goodness of Fit Hosmer-Lemeshow test A p 005 will be considered statistically significant for all the comparisons
The following data were entered in the database Age gender and body mass index previous medical history and more specifically the presence of cardiac insufficiency chronic renal failure defined as an estimated glomerular filtration rate less than 60 mlmin173 m-1 chronic respiratory illness neurologic background diabetes neoplasia history previous TBI active smoking and chronic alcoholism Mechanism of injury domestic accident road traffic crash fall from heights or others The Glasgow Coma Score GCS score determinates in the prehospital setting or at admission at hospital before intubation andor sedation and the presence of at least one nonreactive and dilated pupil at the initial management Severity of illness according to the Simplified Acute Physiology Score II SAPS II the Sequential Organ Failure Assessment SOFA score and the Injury Severity Score ISS The investigators also specified the severity of TBI by the abbreviated Injury Score AIS and reported the associated injuries from 5 territories face chest abdomen extremity including pelvis and external Initial CT-scan was classified according to the Marshall classification in six categories Diffuse injury I II III IV evacuated mass V and non-evacuated mass lesion VI
The following data during the patients hospitalization are also entered in the database use of an intracranial pressure ICP catheter occurrence of intracranial hypertension defined as an ICP above 20 mmHg in absence of confounding factors and use of barbiturates andor osmotherapy decompressive craniectomy and other neurosurgical procedure The occurrence of intercurrent events occurring during ICU stay including infections Acute Respiratory Distress Syndrome ARDS need of vasopressor drugs acute renal failure thrombophlebitis pulmonary embolism hemorrhage infection and tracheostomy The investigators specified the need for intubation and durations of mechanical ventilation central venous catheterism and vasopressor The investigators also recorded the decision in ICU to withdraw or withhold life support
The length of stay in ICU ICU and 3-month mortalities and patient outcome were assessed using the Glasgow Outcome Scale Extended GOSE score at 3 months The investigators dichotomized the GOSE score between the four lower values corresponding to unfavorable outcome- GOSE 1 to 4 and the four upper values corresponding to favorable outcome- GOSE 5 to 8
Statistical Analysis All statistical analysis will be performed using R software 331 package pROC and SAS 91 Statistical Software SAS Institute Cary NC USA For quantitative continuous variables position and dispersion parameters mean standard deviation median interquartile range will be calculated For qualitative variables proportion rates will be calculated For groups comparison we used independent-samples t-tests for normally distributed continuous variables and Mann-Whitney U-tests for non-normally distributed continuous variables Χ² tests will be performed for categorical variables To build the model for multivariate analysis the investigators selected among the variables with a p 020 according to the univariate analysis The investigators performed logistic regression model to identify factors associated with in-ICU mortality and dichotomized GOSE score at 3 months The Odds Ratios ORs and 95 confidence intervals CI will be calculated For continuous variables diagnosis of log linear behavior was established and if not confirmed the variable will be divided into categories and treated as categorical variables Models fit will be assessed by checking residual plots and Cooks distance The calibration of the model will be tested by Goodness of Fit Hosmer-Lemeshow test A p 005 will be considered statistically significant for all the comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None