No registrations found.
ID
Source
Brief title
Health condition
ischemic stroke
fatigue
pituitary dysfunction
Sponsors and support
Intervention
Outcome measures
Primary outcome
To assess the difference in prevalence of pituitary dysfunction between patients with and patients without fatigue after ischemic stroke.
Secondary outcome
1. To assess the time course of pituitary dysfunction after ischemic stroke.
2. To assess predictors of pituitary dysfunction after ischemic stroke, including stroke severity, stroke location and demographic factors.
3. To assess the association between pituitary dysfunction and depression, cognitive performance and functional status after ischemic stroke.
4. To assess independent predictors for poststroke fatigue, including pituitary dysfunction, depression, use of medication, comorbidity, laboratory disturbances, pain, illness representation, stroke location, stroke severity and sleep apnoea disorder.
5. To assess the association between fatigue and functional status after ischemic stroke.
Study objective
The hypothesis is that poststroke fatigue is associated with pituitary dysfunction.
Other factors associated with poststroke fatigue, e.g. sleep apnoea and laboratory dysfunction, will be investigated as well.
Study design
Patients will be assessed at enrolment, and at 3 months, 6 months and 12 months thereafter.
Intervention
Besides standard treatment at enrolment, patients will undergo a general physical examination, a questionnaire, a cognitive performance test, a polygraph, a standardized fasting blood test and a routine hormone screening protocol. In case of abnormal hormonal values, additional tests will be performed to assess the level of dysfunction.
Department of Intensive Care
P.O. Box 7057
A. Beishuizen
Clinical research, Intensive Care
Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31(0)20 444444492
beishuizen@vumc.nl
Department of Intensive Care
P.O. Box 7057
A. Beishuizen
Clinical research, Intensive Care
Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31(0)20 444444492
beishuizen@vumc.nl
Inclusion criteria
A subject must meet all of the following criteria:
- 18 years or older;
- NIHSS score12 of ¡Ý 2;
- be expected to be discharged to a rehabilitation unit or to home.
Exclusion criteria
Patients will be excluded when they:
- are being treated with chemotherapeutics;
- are receiving (oral or intravenous) corticosteroid therapy for more than 1 month (not: inhalation corticosteroids);
- are pregnant;
- are not able to complete a questionnaire due to severe aphasia, non-Dutch speaking or severe cognitive disturbances;
- have a history of hypothalamic/pituitary disease that significantly affects the study results, e.g. Cushing¡¯s disease, cranial irradiation or another significant intracranial lesion, multiple sclerosis, chronic fatigue syndrome and/or psychiatric condition that interferes with interpretation of the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5182 |
| NTR-old | NTR5330 |
| CCMO | NL52674.044.15 |
| OMON | NL-OMON47027 |