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 |
| Protocol serial number | N/A |
| Sponsor | VU University Medical Centre (VUMC) (The Netherlands) |
| Funder | VU University Medical Centre (VUMC) (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Interventional, non-randomised, pharmacokinetic study |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Nimodipine |
| Primary outcome measure(s) |
1. Pharmacokinetics of nimodipine in this specific group of patients |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
