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Grant: Operating Grant

Université Laval

$278,469.00

Clinical outcomes and predictors of PITuitary disorders in patients with moderate and severe Traumatic Brain Injury: the PIT-TBI prospective multicenter pilot cohort study.

EF 2013-14

Résumé
Damage to the pituitary gland, located at the base of the brain, is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. We will enroll 70 patients with moderate or severe TBI admitted to 6 Canadian intensive care units. Each patient will undergo hormonal and disability assessment in the intensive care unit, prior to hospital discharge, at 6 months and at 1 year. We will collect data on baseline characteristics, trauma severity, and interventions used to care for each patient. If more than 90% of patients undergo adequate hormonal and clinical assessment and if each participating center enrolls an average of 1 patient every 3 weeks, we will proceed with the larger study. Our results will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, our findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.
Programme
Operating Grant
Bénéficiaire
Emplacement
Quebec, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
293333
Name
Lauzier François
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Clinical Investigation - C: Digestive, Endocrine and Excretory Systems
Projecttitle
Clinical outcomes and predictors of PITuitary disorders in patients with moderate and severe Traumatic Brain Injury: the PIT-TBI prospective multicenter pilot cohort study.
Programtype2
Operating Grants
Orgnameinp2
Université Laval
Cihramount2
$278,469
Cihrequipment2
$0
Programname2
Operating Grant
Keyworddelim
Critical Care; Outcome Research; Patient Oriented Research; Pituitary Disorders; Risk Factors; Traumatic Brain Injury
Abstract
Damage to the pituitary gland, located at the base of the brain, is a frequently overlooked but potentially important complication of traumatic brain injury (TBI). Disorders of the pituitary gland can cause dysfunction of the thyroid, adrenals, ovaries and testes. These disorders may occur immediately or several months after TBI, may delay recovery and have a significant negative impact on quality of life. TBI is the leading cause of disability and major permanent functional impairment among adults under 45 years of age. Hormonal deficits may contribute to common symptoms experienced by TBI survivors such as fatigue, poor concentration, depression and low exercise capacity. However, the association between hormonal deficits and disability remains uncertain. The primary objective of this pilot study is to assess the feasibility of a larger study that will evaluate the impact of pituitary disorders on neurological disability and functional recovery. We will enroll 70 patients with moderate or severe TBI admitted to 6 Canadian intensive care units. Each patient will undergo hormonal and disability assessment in the intensive care unit, prior to hospital discharge, at 6 months and at 1 year. We will collect data on baseline characteristics, trauma severity, and interventions used to care for each patient. If more than 90% of patients undergo adequate hormonal and clinical assessment and if each participating center enrolls an average of 1 patient every 3 weeks, we will proceed with the larger study. Our results will provide key findings in the impact of pituitary disorders following TBI, which is a mandatory step prior testing the effect of hormonal replacement therapy in this population in costly clinical trials. If no relationship between pituitary disorders and disability is observed, our findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.
Competitiondate
201309
Approvedterm2
3 yrs 0 mth
Pinamesdelim
Lauzier, François
Approvedterm
3 ans 0 mois
Cihrcontribution2
~ $278,469~ $0~