The pharmacokinetics of nimodipine, intravenous and orally, in patients with subarachnoidal haemorrhage admitted in intensive care
| ISRCTN | ISRCTN45381163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45381163 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 04/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B M Kors
Scientific
Scientific
VU University Medical Centre
Afdeling intensive care volwassenen
Boelelaan 1117
Amsterdam
1081 HV
Netherlands
| Phone | + 31 (0)20 444 3900 |
|---|---|
| bm.kors@vumc.nl |
Study information
| Study design | Interventional, non-randomised, pharmacokinetic study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Describing the pharmacokinetics of nimodipine, especially the variability of the bio-availability of orally administred nimodipine. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Subarachnoidal haemorrhage |
| Intervention | Blood samples according to strict time protocol during treatment. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nimodipine |
| Primary outcome measure | 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 study start date | 01/12/2006 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 12 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2006 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
VU University Medical Centre (VUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Intensive Care
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Website | http://www.vumc.nl/english/ |
|---|---|
"ROR" |
https://ror.org/00q6h8f30 |
Funders
Funder type
Hospital/treatment centre
VU University Medical Centre (VUMC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
