To determine the incidence of hypopituitarism in patients after SAHTo identify neurological parameters that predict hypopituitarism after SAHTo determine the value of a Ghrelin test shortly after SAH, to identify subjects with GHD.To determine theā¦
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the incidence and potential riskfactors of hypopituitarism in patients after a
SAB
potential base line SAB riskfactors: hydrocephalus, extravasated blood, delayed
cerebral ischemia, glasgow coma scale in relation with hypopituitarism.
Secondary outcome
1) Incidence and potential riskfactors of growthhormone defeciency in patients
after SAB.
2) Value of Ghrelin test for GHD shortly after SAH
3) Difference in physical functioning in patients with hypopituitarism and the
control group, identified by different specific questionnaires.
4) Difference in quality of life in patients with hypopituitarism and the
control group, identified by different specific questionnaires.
5) Difference in level of everyday physical activity and physical funcitoning
(max. oxygen consumption and muscle strength) post SAH and healthy controls.
Background summary
Spontaneous subarachnoidal hemorrhage (SAH) occurs with an incidence of six
cases per 100.000 patient years, with a case mortality amounting to 50% (1). In
patients who survived SAH, high rates of functional limitations are found along
with quality-of-life impairment, such as fatigue, decreased mobility, loss of
motivation, reduced independence in activities of daily living and decreased
social functioning (1,2).
The residual functional problems in patients after SAH are often unexplained,
but may largely resemble those occurring in patients with untreated
hypopituitarism. Corticotrophin and TSH deficiency may present with symptoms
such as fatigue, weakness, headache, altered mental activity or impaired
memory. Symptoms attributable to Growth Hormone deficiency include lack of
vigor, decreased exercise tolerance and decreased social functioning with loss
of quality of life (2).
Recent studies in long-term survivors of SAH have shown varying incidences
(from 20 up to 50%) of hypopituitarism, with growth hormone deficiency (GHD)
occurring in 15 - 25% of patients (3,2,4,5). This neuroendocrine dysfunction
could be the result of damage to the hypothalamic/pituitary system caused by
post hemorrhagic local tissue pressure, toxic effects of the extravasated
blood, ischemia caused by vasospasm, high intracranial pressure, hydrocephalus
or local destruction during cerebral surgery. At present, it is not possible to
identify which SAH patients are at risk of developing hypopituitarism. The
clinical effects of optimal hormone replacement therapy on residual symptoms in
SAH patients is unknown.
Measuring Healthy controls.
Adequate norm values for the SAH patients concerning fitness, muscle strength
and activity pattern are lacking. However, these norm values are necessary to
interpret the results for evaluating the effects of SAH on physcial
functioning. This knowledge can be used to optimise rehabilitation programs
after SAH which may reduce the residual complaints.
Study objective
To determine the incidence of hypopituitarism in patients after SAH
To identify neurological parameters that predict hypopituitarism after SAH
To determine the value of a Ghrelin test shortly after SAH, to identify
subjects with GHD.
To determine the impact of hypopituitarism on physical functioning, activity
pattern and participation.
To evaluate the effect of GH replacement on residual functional physical
fitness, fatigue and quality of life.
To evaluate physical functioning (cardiorespiratory and neuromuscular fitness),
activity pattern and fatigue in patients post SAH.
Study design
This is a prospective clinic-based cohort study
Study burden and risks
The study consists of 7 visits to our hspital for patients with
hypopituitarism. Patient without hypopituitaris only need to bring two vists to
our hospital. During these visits which will last for 66 weeks, we will
evaluate the patients by specific questionnaires. Bloodsampling will take place
according to the study flowchart in every visit. Two of the visits in week 24
and 60 will take longer than normal because of more extensive evaluation, the
visit in week 24 is only for patients with hypopituitarism and in week 60 for
all the patients included in the study. Patients with hypopituitarism will be
treated by the endocronologist comitted to this study.
Measuring Healthy controls.
All tests can be taken during one session of approximately 2,5 hours. The
measurements take place in the human movement laboratory of the department of
Rehabilitation Medicine and Physical Therapy of Erasmus MC. Controls will be
screened using a Par-Q quenstionaire, a Sportmedical questionaire and a
physical examintion before maximal testing.
s-Gravendijkwal 230
Rotterdam 3015CE
NL
s-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
Subarachnoid hemorrhage
Age >= 18 years
Discharge from ICU
Signed and dated informed consent document;Controls will be patient-matched on age (+/- 5 years) and gender.
Exclusion criteria
Any hypothalamic/pituitary disease diagnosed prior to SAH.
History of cranial irradiation
Prior significant trauma capitis
Another significant intracranial lesion (apart from SAH or its sequellae)
Any other medical or psychiatric condition or laboratory abnormality that may impose a risk for participation in the study or interfere with the interpretation of the study (according to the judgment of the investigators).;Exclusion criteria healthy controls: individuals with deficits which affect physical fitness or activity (eg amputations, hip/knee prosthesis, cognitive problems), individuals at risk for health issues because of maximal testing (according to the Par Q checklist).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL22291.078.08 |