search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Fatigue after ischemic stroke: association with pituitary dysfunction


- candidate number22502
- NTR NumberNTR5330
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2015
- Secondary IDsNL52674.044.15 
- Public TitleFatigue after ischemic stroke: association with pituitary dysfunction
- Scientific TitlePituitary dysfunction in association with fatigue after ischemic stroke
- ACRONYMPIT-FAST
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedIschemic stroke, Fatigue, Pituitary disease
- Inclusion criteriaA subject must meet all of the following criteria:
- 18 years or older;
- NIHSS score12 of ¡Ư 2;
- be expected to be discharged to a rehabilitation unit or to home.
- Exclusion criteriaPatients 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.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate1-okt-2017
- Target number of participants118
- InterventionsBesides 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.
- Primary outcomeTo assess the difference in prevalence of pituitary dysfunction between patients with and patients without fatigue after ischemic stroke.
- Secondary outcome1. 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.
- TimepointsPatients will be assessed at enrolment, and at 3 months, 6 months and 12 months thereafter.
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIESdr. A. Beishuizen
- CONTACT for SCIENTIFIC QUERIESdr. A. Beishuizen
- Sponsor/Initiator Medisch Spectrum Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD24-jul-2015 - 25-aug-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl