Contact information
Type
Scientific
Primary contact
Dr B M Kors
ORCID ID
Contact details
VU University Medical Centre
Afdeling intensive care volwassenen
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+ 31 (0)20 444 3900
bm.kors@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Describing the pharmacokinetics of nimodipine, especially the variability of the bio-availability of orally administred nimodipine.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Interventional, non-randomised, pharmacokinetic study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Subarachnoidal haemorrhage
Intervention
Blood samples according to strict time protocol during treatment.
Intervention type
Drug
Phase
Not Specified
Drug names
Nimodipine
Primary outcome measures
1. Pharmacokinetics of nimodipine in this specific group of patients
2. Variability of bio-availability of orally administred nimodipine
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/12/2006
Overall trial end date
01/12/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients admitted to the Intensive Care Unit (ICU) with subarachnoidal bleeding/haemorrhage (SAB), treated according to our SAB-protocol
2. Adults aged 18 to 70 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. Pregnancy
2. Expected mortality in less than 24 hours
3. Severe hepatic function disorders
4. Use of medication with known interaction in relation to nimodipine
Recruitment start date
01/12/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Centre
Amsterdam
1081 HV
Netherlands
Sponsor information
Organisation
VU University Medical Centre (VUMC) (The Netherlands)
Sponsor details
Department of Intensive Care
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
VU University Medical Centre (VUMC) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary