Clinical trial NCT02480985: The PIT-TBI Pilot Study
Official title: Clinical Outcomes and Predictors of PITuitary Disorders in Patients With Moderate and Severe Traumatic Brain Injury: the PIT-TBI Prospective Multicenter Pilot Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Disorders
Traumatic Brain Injury
Keywords: Pituitary Disorders
Traumatic Brain Injury
Critical Care
Outcome Research
Risk Factors
Patient Oriented Research
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Canadian Critical Care Trials Group
name: Fonds de la Recherche en Santé du Québec
First posted: 2015-06-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Damage to the pituitary gland 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 may 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. The results of this study 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, the investigators' findings will prevent unnecessary, time-consuming and costly hormonal screening and will discourage potentially harmful hormonal therapy.


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years old)
* Severe or moderate blunt TBI admitted to the ICU with a Glasgow Coma Scale ≤ 12 following initial resuscitation

Exclusion Criteria:

* Previously diagnosed or suspected pituitary disorder or disease
* Pregnant or lactating woman
* Penetrating TBI
* Solid malignancy with life expectation \<12 months
* Liver Cirrhosis Child C
* Chronic Heart Failure (New York Heart Association class IV)
* End-stage chronic respiratory disease (O2 dependent)
* End-stage renal disease (chronic dialysis or to be expected)
* Neurological conditions influencing functional status (e.g. spinal cord injury, neuromuscular disease, dementia, prior TBI or stroke)
* No fixed address
* Physician refusal
* Brain death
* Unable to return to the study center to attend the follow-up visits
* Admission to the Intensive Care Unit of the participating center \> 24 hours after TBI

Primary outcomes:
measure: Adherence to the Protocol
timeFrame: 12 months
measure: Enrollment Rate
timeFrame: 12 months
Secondary outcomes:
measure: Neurological Recovery
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Independent functioning
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Life satisfaction
timeFrame: 12 months
measure: Secondary hypothyroidism
timeFrame: 12 months
measure: Secondary hypogonadism
timeFrame: 12 months
measure: Secondary adrenal insufficiency
timeFrame: 12 months
measure: Growth hormone deficit
timeFrame: 12 months
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Montreal
country: Canada
facility: Hôpital du Sacré-Coeur de Montréal
state: Quebec
city: Sherbrooke
country: Canada
facility: CHU de Sherbrooke - Hôpital Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec - Hôpital de l'Enfant-Jésus
Study officials:
affiliation: CHU de Quebec Research Center
name: François Lauzier, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauzier F, Turgeon AF, Boutin A, Shemilt M, Cote I, Lachance O, Archambault PM, Lamontagne F, Moore L, Bernard F, Gagnon C, Cook D. Clinical outcomes, predictors, and prevalence of anterior pituitary disorders following traumatic brain injury: a systematic review. Crit Care Med. 2014 Mar;42(3):712-21. doi: 10.1097/CCM.0000000000000046.